KENTEX DISPOSABLE VAGINAL SPECULUM

{0}------------------------------------------------ K030693 ## KENTRON HEALTH CARE, INC 3604 KELTON JACKSON ROAD P.O. BOX 120 SPRINGFIELD, TN 37172 Email: Kenorex@aol.Com Phone: 615-384-0573 Fax: 615-384-0574 > Premarket Notification 510K Summary of Safety and Effectiveness KENTEX Disposable Vaginal Speculum Company Information: KENTRON HEALTH CARE, INC 3604 KELTON JACKSON ROAD SPRINGFIELD, TN 37172 CONTACT: NARI SADARANGANI, MD SUMMARY PREPARATION DATE: MARCH 4, 2003 DEVICE INFORMATION: | TRADE NAME: | KENTEX DISPOSABLE<br>VAGINAL SPECULUM | |-------------|---------------------------------------| |-------------|---------------------------------------| DISPOSABLE VAGINAL COMMON NAME: SPECULUM NON METAL VAGINAL CLASSIFICATION NAME: SPECULUM CLASSIFICATION PANEL: REGULATION NUMBER: 21CFR PART 884.4530 CLASS OBSTRETICS AND GYNECOLOGY 11 PRODUCT CODE: HIB {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains an abstract image of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are written around the top half of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 7 2003 Sadarangani, MD, FACC, FCCP President Kentron Health Care, Inc. 3604 Kelton Jackson Road P.O. Box 120 SPRINGFIELD TN 37172 Re: K030693 Trade/Device Name: Kentex Disposable Vaginal Speculum Regulation Number: 21 CFR 884.4530 Regulation Name: Obtsetric-gynecologic specialized manual instrument Regulatory Class: II Product Code: 85 HIB Dated: June 23, 2003 Received: July 30, 2003 Dear Dr. Sadarangani: 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 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 Federal 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 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ 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 one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html. Sincerely vours. Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K030693/A' Page 510(K) NUMBER (IF KNOWN) KO30693 DEVICE NAME: KENTEX VAGINAN SPECULUM DISPOSABLE KENTEX DiSPoSABLE VAGINA CARACTORA CONSULERAL GUARES INDICATIONS FOR USE: INTENDED TO BE USED FOR GENERAL THE UNGINA PROCEDURES. IT is INSERTED INTO THE VAGINA TRUCTOURES THE INTERioR OF THE VAGINA. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter-Use (Per 21 CFR 801.109) (Optional Format 1-2-96) (Division Sign-Off) Division of Reproductive, Aucional, and Radiological Devices 510(k) Number K030693 SK 5.4