FERRIS POLYMEM STERILE BREAST PAD

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle. FEB 2 2 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. John Newton Global Director, Product and Market Management Ferris Manufacturing Corporation 16W300 83" Street Burr Ridge, Illinois 60527-5848 Re: K031660 Trade/Device Name: Ferris PolyMem® STERILE BREAST PAD Regulation Number: 880.5630 Regulation Name: Nipple Shield Regulatory Class: I Product Code: NTX Dated: November 22, 2004 Received: November 24, 2004 Dear Mr. Newton: 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 Federal Register. {1}------------------------------------------------ Page 2 – Mr. Newton 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. 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 responsibilitics 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, Chiu Lin, Ph.D 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 {2}------------------------------------------------ Page _________________________________________________________________________________________________________________________________________________________________________ 510(k) NUMBER (IF KNOWN): K031660 DEVICE NAME: FERRIS PolyMem® STERILE BREAST PAD INDICATIONS FOR USE: Over the Counter Use: To be worn inside the bra to: - Soothe tender, sore, irritated, cracked or painful nipples caused by breastfeeding . - Absorb milk leakage . - Protect the nipple from abrasion and friction damage caused by bra or clothing . - Help alleviate discomfort . - Protect clothing from milk leakage . (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) Chm Um Wision Sim-Off) in islon of anesthesiology. General Hospital, Intection Control. Dental Devices 709(K) number K5 3/609