Who is the manufacturer of AMIGO INSULIN PUMP?

Nipro Diabetes Systems, Inc. filed the 510(k) submission for AMIGO INSULIN PUMP (K071613).

What is the FDA product code for AMIGO INSULIN PUMP?

LZG. It is classified under 21 CFR 880.5725 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for AMIGO INSULIN PUMP?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AMIGO INSULIN PUMP?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AMIGO INSULIN PUMP

Q: What are the predicate devices for AMIGO INSULIN PUMP?

Animas IR1250 Insulin Infusion Pump (K042873); Nipro Amigo® Insulin Pump (K050312); Smiths Medical Deltec Cozmo® Insulin Pump (K062323).

K071613 · Nipro Diabetes Systems, Inc. · LZG · Dec 14, 2007 · General Hospital

Device Facts

Record ID	K071613
Device Name	AMIGO INSULIN PUMP
Applicant	Nipro Diabetes Systems, Inc.
Product Code	LZG · General Hospital
Decision Date	Dec 14, 2007
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5725
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

The Amigo® Insulin Pump is intended for the subcutaneous infusion of insulin.

Device Story

Amigo® Insulin Pump is a battery-operated, programmable infusion device for subcutaneous insulin delivery. It utilizes a microcomputer-controlled stepper motor and gear reduction assembly to drive a linear piston, which mechanically engages a single-use 3mL insulin syringe. The device is operated by the patient via a keypad and LCD interface to program basal and bolus insulin delivery. It features audible, visual, and vibration alarms based on IEC 60601-1-8 to notify users of error conditions or occlusion. Power is supplied by a primary CR2 battery with an internal rechargeable backup for redundancy. The device is intended for personal use to manage diabetes, helping patients maintain glycemic control through precise insulin administration. Healthcare providers use the device's programmed settings to tailor insulin therapy to individual patient needs.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and infusion pump safety (IEC 60601-2-24). Testing verified flow rate accuracy, occlusion detection, alarm functionality, and water ingress protection (IPX8).

Technological Characteristics

Linear piston infusion pump; stainless steel gear reduction assembly; microcomputer-controlled stepper motor. Powered by primary CR2 lithium battery with internal rechargeable backup. Dimensions: 3.28 x 2.18 x 0.93 inches; weight: 3.1 oz. Connectivity: Infrared port (manufacturing use only). Software: Programmable basal/bolus delivery, alarm hierarchy per IEC 60601-1-8. Environmental: IPX8 rated. Sterilization: Not specified (disposable syringe/infusion set used).

Indications for Use

Indicated for the subcutaneous infusion of insulin for the management of diabetes mellitus in patients requiring insulin therapy.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

Animas IR1250 Insulin Infusion Pump (K042873)
Nipro Amigo® Insulin Pump (K050312)
Smiths Medical Deltec Cozmo® Insulin Pump (K062323)

Submission Summary (Full Text)

{0}------------------------------------------------ K071613 f. lot 12 3361 Enterprise Way Miramar, Florida 33025 Tel: (954) 435-5665 Fax: (954) 435-9295 www.niprodiabetes.com Image /page/0/Picture/2 description: The image shows the logo for Nipro Diabetes Systems. The word "NIPRO" is in large, bold, black letters on the top line. Below that, the words "DIABETES SYSTEMS" are in smaller, bold, black letters. DEC 1 4 2007 ## "510(k) Summary" ### Amigo® Insulin Pump Owner: Address: Phone: FAX: Name of contact person: Date prepared: Submission type: Proprietary name: Common name(s): Classification name: Device class: Panel: Product code: Regulation: Establishment registration: Predicate device(s) Nipro Diabetes Systems, Inc 3361 Enterprise Way Miramar, FL 33025 (954)-435-5665 (954)-272-0438 Harry Russell November 5, 2007 Traditional 510(k) Amigo® Insulin Pump Insulin pump Pump, infusion, insulin 11 80 (General hospital and personal use devices) 80LZG 21 CFR § 880.5725 Nipro Diabetes Systems, Inc. #1066380 Animas IR1250 Insulin Infusion Pump K042873 Nipro Amigo® Insulin Pump K050312 Smiths Medical Deltec Cozmo® Insulin Pump K062323 {1}------------------------------------------------ # DEVICE DESCRIPTION The proposed Amigo® Insulin Pump is a small, lightweight, battery-operated programmable insulin infusion pump. The pump houses a replaceable single-use insulin syringe containing up to 300 units (3mL) of U-100 insulin. Programming is accomplished via a keypad and LCD display. A microcomputer controls the rotation of a stepper-motor which is connected to a gear reduction assembly. The output of the reduction assembly turns a lead-screw which moves a linear piston. The piston mechanically engages the plunger of the insulin syringe, and the programmed amount of insulin is dispensed through an external seal and luer lock connector to an infusion set. Various hardware and software systems monitor the pump's operation and provide a method of control and monitor function to keep the pump within safe parameters. A hierarchy of alarms based on IEC 60601-1-8 criteria and priorities notifies the user to possible error conditions. Notifications are via visual, audible, and vibration means through the use of the LCD backlight, the audio speaker, and a vibrator motor, respectively. If the alarm priority warrants, the system is put into a safe state with infusion stopped. Power is provided by a user-replaceable primary battery (CR2), allowing for a minimum of 22 days of typical usage. An internal, rechargeable backup battery is used for primary battery end-of-life alarms and for operating redundancy. Provision is made for an infrared communications port, which is accessible only to Nipro for manufacturing use. #### INTENDED USE The Amigo® Insulin Pump is intended for the subcutaneous infusion of insulin. #### COMPARISON WITH THE PREDICATE DEVICE The following table compares the Amigo® Insulin Pump with its predicate devices, the Animas IR1250 Insulin Infusion Pump, the Nipro Amigo® Insulin Pump, and the Smiths Medical Deltec Cozmo® Insulin Pump. Areas of minor difference are shaded, with discussion on the difference(s) immediately to the right. {2}------------------------------------------------ | Characteristic | | Animas IR1250 Insulin Infusion Pump (Predicate Device) | Amigo® Insulin Pump (Predicate Device) | Smiths Medical Deltec Cozmo Pump (Predicate Device) | New Amigo® Insulin Pump (This Submission) | Discussion | |------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | | 510(k) Number | K042873 | K050312 | K062323 | N/A | | | General | Intended Use | Intended to provide subcutaneous delivery of insulin at programmable basal and bolus rates for the daily management of diabetes mellitus in insulin dependent patients | Intended for the subcutaneous infusion of insulin. | Designed for Continuous Subcutaneous Insulin Infusion (CSII) for the control of diabetes. | Intended for the subcutaneous infusion of insulin. | | | | Pump Type | Linear Piston | Linear Piston | Pushrod | Linear Piston | | | | Power transmission | Plastic gears | Stainless steel gears | Not available | Stainless steel gears | | | | Dimensions | 2.9 x 2.0 x 0.76 inches | Less than 3.54 x 2.36 x 1.18 inches | 3.2 x 1.8 x 0.95 inches | 3.28 x 2.18 x 0.93 inches | | | | Weight | 3.13 ounces | Less than 3.2 ounces | Approx. 3.2 ounces | 3.1 ounces | | | Characteristic | Animas IR1250 Insulin Infusion Pump (Predicate Device) | Amigo® Insulin Pump (Predicate Device) | Smiths Medical Deltec Cozmo Pump (Predicate Device) | New Amigo® Insulin Pump (This Submission) | Discussion | | | Control Technology | Microprocessor | Microprocessor | Microprocessor | Microprocessor | The new Amigo pump has a backup battery for redundancy, and mitigation of end-of-primary-battery-life issues. | | | Insulin Reservoir) | 2 mL (200 Units) | 3 mL (300 Units) | (300 Units) | 3 mL (300 Units) | | | | Insulin Type | Rapid-acting U-100 insulin or regular (short-acting) U- 100 insulin | U100 | | Rapid-acting or short-acting U-100 insulin | | | | Power Source | One 1.5 Volt lithium battery | One 3 Volt lithium primary battery | One AAA alkaline battery | One 3 Volt lithium primary battery (replaceable); one lithium cell backup battery (internal) | | | | Programmable Basal Delivery | Yes | Yes | Yes | Yes | | | | Programmable Bolus Delivery | Yes | Yes | Yes | Yes | | | | User Notification | Audible, visual, and vibration | Audible, visual, and vibration | Audible and vibration | Audible, visual, and vibration | | | | Characteristic | Animas IR1250 Insulin Infusion Pump (Predicate Device) | Amigo® Insulin Pump (Predicate Device) | Smiths Medical Deltec Cozmo Pump (Predicate Device) | New Amigo® Insulin Pump (This Submission) | Discussion | | | Visual Display | LCD | LCD | LCD | LCD | | | | Insulin Syringe / reservoir | Animas disposable cartridge | GlucoPro syringe, single-use reservoir (K014114) | Deltec Cozmo 3 ml Insulin Cartridge (21-1750) | GlucoPro syringe, single-use reservoir (K014114) | | | | Infusion Set Connector | Standard luer lock | Standard luer lock | Standard luer lock | Standard luer lock | | | | Flow Rate Accuracy Bolus | +/- 5% | +/- 5% | +/- 15% at 0.1 U +/- 1.5% at 25 U | +/- 5% | | | | Basal | +/- 5% (0.1 U/hr or greater) | +/- 5% (0.1 U/hr or greater) | +/-2% (nominal) except at low delivery rates | +/- 5% (0.5 U/hr or greater) | The Animas maintains +/- 5% accuracy at slightly lower flow rates; (The Deltec unit nominal % does not compare to the absolute % of Animas and Amigo). | | | Basal Basal rate adjustment range | 0.025 - 25U/hr in .025 U/hr steps | 0.00 - 30.00U/hr in .05U/hr steps Normal, Temporary | 0.00 - 35.00 U/hr in 0.05 U/hr steps Normal / Temporary | 0.00 - 30.00U/hr in .05U/hr steps Normal, Temporary | | | | Basal Profiles Basal Rates | 4 Up to 12 basal rates | 1 to 4 48 available per profile in 15 minute increments | 4 48 available per profile in 30 minute increments | 1 to 4 48 available per profile in 15 minute increments | | | | Characteristic | Animas IR1250 Insulin Infusion Pump (Predicate Device) | Amigo® Insulin Pump (Predicate Device) | Smiths Medical Deltec Cozmo Pump (Predicate Device) | New Amigo® Insulin Pump (This Submission) | Discussion | | | Temporary, Basal Mode | 30 min - 24 hr Adjusted in 30 minute intervals; | 15 min - 24 hr Adjusted in 15 minute intervals; | 30 min - 72 hr Adjusted in 30 minute intervals; | 15 min - 24 hr Adjusted in 15 minute intervals; | Ranges are substantially equivalent. | | | Basal Insulin Delivery Frequency | -90% to 200% in 10% increments 3 minutes | As a Percent (%) of active profile; 10 - 200% in 10% increments 3 or 15 minutes | As a Percent (%) of active profile; 0 - 250% in 5% increments 3 minutes (0.1 U/h or higher); significantly longer for rates less than 0.1 U/h) | As a Rate in U/h or as a Percent (%) of active profile; 10 - 200% in 10% increments 3 or 15 minutes | The new Amigo Insulin Pump also allows programming as a rate in U/hr | | | Bolus Adjustment Range | 0.05U - 35 U in 0.05U steps | 0.05 to 30.00U in 0.05U steps Normal, Extended and Layered | 0.00 - 75.00 U in 0.05 to 5.00 U steps (steps are settable) Meal, Extended, and Combination | 0.05 to 30.00U in 0.05U steps Normal, Extended and Layered | | | | Direct Bolus Increment | 0.1 - 2.0U in 0.1 U steps 0.5 - 10.0U in 0.5 U steps 1.0 - 20.0U in 1.0 U steps 5.0 - 35.0U in 5.0 U steps | 0.1 to 5.0U in 0.1 U steps | 0.05, 0.10, 0.50, 1.00, 2.00, or 5.00 U. | 0.1 to 5.0U in 0.1 U steps | | | | Bolus Estimator | Yes | Yes | Yes | Yes | | | | Characteristic | Animas IR1250 Insulin Infusion Pump (Predicate Device) | Amigo® Insulin Pump (Predicate Device) | Smiths Medical Deltec Cozmo Pump (Predicate Device) | New Amigo® Insulin Pump (This Submission) | Discussion | | | Delivery Rates - Bolus | 0.2 U/sec to 2.2 U/sec | 0.07 U/sec to 0.2 U/sec | 0.01 U / sec to 2.5 U/sec | 0.2 U/sec | The Amigo pump has a fixed bolus rate that matches an allowed rate within the ranges of all of the predicate devices. | | | Delivery Rates - Prime | 1.8 - 2.9 U/sec | Not available | 1.0 U / sec | 1.0 U/sec | | | | Max. Volume infused under single fault conditions | Max 2.0U | Not available | Less than 2 units | Max 1.5 U | | | | Occlusion Detection Time to Alarm | | | | | | | | Basal | 72 hrs - 120 hrs (0.025 U/h basal) Typical - Maximum | Not available | 37 hours - 74 hours (0.05 U/h) Minimum - Maximum | 58 hours 20 min - 88 hours 40 minutes (0.10 U/h basal) Minimum - Maximum | | | | Basal | 90 min - 3 hours (1.0 U/h basal) Typical - Maximum | Not available | 60 min - 3.9 hours (2.0 U/h basal) Minimum - Maximum | 85 min - 88 minutes (1.00 U/h basal) Minimum - Maximum | | | | Characteristic | Animas IR1250 Insulin Infusion Pump (Predicate Device) | Amigo® Insulin Pump (Predicate Device) | Smiths Medical Deltec Cozmo Pump (Predicate Device) | New Amigo® Insulin Pump (This Submission) | Discussion | | | Occlusion Pressure Threshold | 75 kPa – 241kPa | 15 psi, 25 psi, 35 psi (104 kPa, 172.5 kPa, 241.5 kPa) | 18 psi +/- 5 psi (13 psi to 23 psi) | Low (15 psi nominal), High (35 psi maximum) (104 kPa, 241.5 kPa) | The Cozmo has one setting, Animas and Amigo have two. Maximum (see below) are all below 35 psi. | | | Maximum Occlusion Pressure | 241kPa (35 psi) | 35 psi | 23 psi | 35 psi | | | | Bolus Volume after Occlusion Release | 1.0 U with occlusion sensitivity set to high 3.0 U with occlusion sensitivity set to low (1.0U/hr basal) | Not available | Approx. 4 U | 0.65 U with occlusion pressure set to low 0.79 U with occlusion pressure set to high (1.0U/hr basal) | The Amigo Insulin Pump compares favorably with the predicate devices. | | | Miscellaneous Infrared Communication Port | Yes | Yes (for manufacturing use only) | Yes | Yes (for manufacturing use only) | | | | Characteristic | Animas IR1250 Insulin Infusion Pump (Predicate Device) | Amigo® Insulin Pump (Predicate Device) | Smiths Medical Deltec Cozmo Pump (Predicate Device) | New Amigo® Insulin Pump (This Submission) | Discussion | | | Battery capacity | 6-8 week life | Not available | Up to 30 days | Minimum of 22 days based on typical use | The Amigo pump has a shorter battery life. This is not clinically significant, as the user has the ability to change batteries and the pump gives multiple warnings. | | | Infusion Set | 23" Comfort | 23" Unomedical Comfort infusion set K972135 | Unomedical Comfort infusion set | 23" Unomedical Comfort infusion set K972135 | | | | Low Insulin Alarm Setting | 10-50 U in 10 Unit Steps | 10-50 U in 10 Unit Steps | 5-50 U in 1 Unit Steps | 10-50 U in 10 Unit Steps | | | | Environmental IPX8 | Yes | Yes | Yes | Yes | | | | Shipping / Storage Range Temperature | -20 to +60 C / -4 to +140 F | -20 to +60 C / -4 to +140 F | -20 to +60 C / -4 to +140 F | 0 to +60 C / 32 to +140 F | The new Amigo pump has a higher minimum storage temperature. | | | Humidity | 10 to 100% RH, including condensing | 10 to 100% RH, including condensing | Maximum 90% RH, non-condensing | 10 to 100% RH, including condensing | | | | Pressure / Altitude | 50-106 kPa / 18281 to -1253 feet | 50-106 kPa / 18281 to -1253 feet | 70-106 kPa / to 10,000 feet above sea level | 50-106 kPa / 18281 to -1253 feet | | | | Characteristic | Animas IR1250 Insulin Infusion Pump (Predicate Device) | Amigo® Insulin Pump (Predicate Device) | Smiths Medical Deltec Cozmo Pump (Predicate Device) | New Amigo® Insulin Pump (This Submission) | Discussion | | | Operating Range Temperature | +5 to +40 C / +40 to +104 F | +5 to +40 C / +40 to +104 F | 2 to +40 C / 35.6 to +104 F | +10 to +40 C / +50 to +104 F | | | | Humidity | 20 to 90% RH, including condensing | 20 to 90% RH, including condensing | Maximum 90% RH, non-condensing | 20 to 90% RH, including condensing | | | | Pressure / Altitude | 70 – 106 kPa / 9878 feet above to 1253 feet below sea level | 70 – 106 kPa / 9878 feet above to 1253 feet below sea level | 70 – 106 kPa / to 10,000 feet above sea level | 70 – 106 kPa / 9878 feet above to 1253 feet below sea level | The new Amigo pump has a slightly higher minimum operating temperature. This is not a clinical issue, as the pump is typically worn against the body, under clothing, in cold weather. | | {3}------------------------------------------------ KC71613 p. 4 of 12 02 -- 0 0 0 6 {4}------------------------------------------------ KC71613p. 5 of 12 {5}------------------------------------------------ {6}------------------------------------------------ K071613p. 7.0f.12 {7}------------------------------------------------ 02-0010 : 071613p.607/12 {8}------------------------------------------------ KC7/613p.207/12 {9}------------------------------------------------ {10}------------------------------------------------ \$\k07/613_{p.11of12}\$ ## NON-CLINICAL PERFORMANCE DATA The Amigo® Insulin Pump was tested for electrical safety and infusion pump performance and safety according to: - IEC 60601-1 (1988): Medical electrical equipment Part 1: General . requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995) - IEC 60601-2-24:1998 Medical Electrical Equipment Part 2-24: ● Particular Requirements For The Safety Of Infusion Pumps And Controllers The Amigo® Insulin Pump was tested for electromagnetic compatibility according to: - IEC 60601-1- 2 Medical Electrical Equipment -- Part 1: General . Requirements for Safety; Electromagnetic Compatibility -- Requirements and Tests (Second Edition, 2001). The Amigo® Insulin Pump also meets: - IEC 60601-1-4:2000 Medical Electrical Equipment Part 1-4: General . Requirements For Safety - Collateral Standard: Programmable Electrical Medical Systems. - ISO 14971:2000 Medical devices Application of risk management to . medical devices. The Amigo Insulin Pump has passed the above testing regimens, including specific testing for flow rates, accuracy, occlusion detection, water ingress, and alarms. ## SUBSTANTIAL EQUIVALENCE A review of the above chart shows that the Amigo® Insulin Pump compares similarly with the predicate devices in all features, with minor differences, as noted, not clinically significant. - . The devices have similar intended uses, use the same insulin type and infusion set, and share similar operating and technological principles. - All devices have similar physical properties and offer similar software . features of bolus and basal combinations and rates. - All devices have nearly identical environmental specifications. . {11}------------------------------------------------ 07/6/3 p. 12 of 12. The above-referenced performance testing data supports the claims of substantial equivalence, that the Amigo® Insulin pump is as safe, as effective, substantial equivalorios, than the predicate devices. {12}------------------------------------------------ Image /page/12/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and health. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 4 2007 Mr. Harry Russell Director of Quality and Regulatory Affairs Nipro Diabetes Systems, Incorporated 3361 Enterprise Way Miramar, Florida 33025 Re: K071613 Trade/Device Name: The Amigo® Insulin Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: LZG Dated: November 8, 2007 Received: December 3, 2007 Dear Mr. Russell: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements {13}------------------------------------------------ Page 2 - Mr. Russell Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Anthony D. Watson for Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {14}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: Indications for Use: K071613 Amigo® Insulin Pump The Amigo® Insulin Pump is intended for the subcutaneous infusion of insulin. Prescription Use _ X ___ AND/OR Over-The-Counter Use (Part21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の人気の Anthony D. Watt Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices 02-0002 10(k) Number:

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