'ECURLINE UMBILICAL CORD CLAMP #3500

{0}------------------------------------------------ 4/6/98 าน รอบ นักกว่า เท่า 13880 Del Sur Street San Fernando California 91340-3490, USA Mailing address: Post Office Box 9043 Van Nuys California 91409-9043, USA Phone: (818) 897-1111 FAX: (818) 899-4045 K990737 Image /page/0/Picture/5 description: The image is a black and white logo. The logo is a shield shape with the letters 'P' and 'D' stacked on top of each other in the center. The letters 'CO' and 'RP' are written in a smaller font below the letters 'P' and 'D'. A registered trademark symbol is located at the bottom right of the logo. ## 510k Summary Precision Dynamics Corporation purchases the umbilical cord clamp (non-sterile) from Alpha Unlimited, Inc (refer to the 510k K894646) and then contracts the packaging and sterilization through ARMM, Inc. ARMM, Inc. packages the umbilical cord clamp in a plastic/film pouch and contract sterilizes the packaged product per Precision Dynamics Corporation specifications. Precision Dynamics Corporation upon receipt of the sterile finished released product from ARMM plans to distribute the Securline ® Cord Clamp. The Securline ® Umbilical Cord Clamp is used to clamp over the umbilical cord of a newborn at delivery. The device is used to hold the cord secruely and prevent blood loss and seepage as the cord dries and shrinks after the birth. Trade Name: Securline ® Umbilical Cord Clamp #3500 Common Name : Umbilical Cord Clamp Classification Name: Umbilical Clamp (per 21CFR section 884.4530(3) Contact : Phone: Fax: Date: Kalyna Snylyk (818)897-1111 x 111 (818)899-4045 March 3, 1999 3.1 {1}------------------------------------------------ Image /page/1/Picture/16 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 6 1999 Ms. Kalyna Snylyk Manager Regulatory Affairs and Quality Assurance Precision Dynamics Corporation 13880 Del Sur Street San Fernando, CA 91340 Re: K990737 Securline® Umbilical Cord Clamp Dated: March 4, 1999 Received: March 5, 1999 Regulatory Class: II 21 CFR 884.4530/Procode: 85 HFW Dear Ms. Snylyk: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled. "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, CARTER R. J. Stitt, M.D. APT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K990737 510(k) Number (if known):_ Device Name: Securline Umbilical Cord Clamp #3500 Indications For Use: : : Umbilical Cord Clamp is used to The Securline clamp over the umbilical cord of a Newborn at delivery. ` The device is used to hold the cord securely and prevent blodd loss and seepage as the cord dries and shrinks after the birth. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number. K990737