AQUAPLAST PALATAL STENT

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUM N SERVICES - USA" arranged around the top half of the circle. In the center of the logo is a stylized image of a caduceus, a symbol of medicine, with a staff entwined by two snakes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC - 2 1997 Mr. John R. Kirk ·President WFR/Aquaplast Corporation 30 Lawlins Park Wyckoff, New Jersey 07481-1443 K973370 Re : Aquaplast Palatal Stent Trade Name: Requlatory Class: II Product Code: EMA Auqust 25, 1997 Dated: Received: September 8, 1997 Dear Mr. Kirk: 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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does {1}------------------------------------------------ Page 2 - Mr. Kirk not affect any obligation you might have under sections 531 not arrect any obtigation for devices under the Electronic Chrough 542 of the Act 101 acvices or other Federal laws or requlations. This letter will allow you to begin marketing your device as Info icecci wirer 510(k) premarket notification. The FDA described in your sia equivalence of your device to a legally rinding of babbeanelar squared in a classification for your marketed production of mits 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) 594-4618. Additionally, for questions on Compriance at (301) 331 1010. Indiarodevice, please contact the Office of Compliance at (301) 594-4639. Also, please note ens or on on on itled, "Misbranding by reference to the regulation entitled, "Misbranding by reference to information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeathed from cho mumber (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, U. Walcott Timot ny A. Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Page 1_of 1 510(k) Number (if known):__K973370 Device Name: PS Thermoplastic (Aquaplast) Palatal Stent - - Indications For Use: Dressing for use after intraoral palatal surgery. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Bunres (Division Sign-Om Division of D and Gen 510(k) Number Prescription Use (Per 21 CFR 801.109) ાવ્યું Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)