MODIFICATION OF MOSS P.E.G. TRAY

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three figures in profile, representing health and human services. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAR 1 7 1999 Moss Tubes, Inc. c/o Mr. Harry A. Schlakman, Attorney at Law Consultant to the Medical Device & Pharmaceutical Industries 304 Verona Avenue Elizabeth, New Jersey 07208 Re: K984628 Moss P.E.G. Tray (Percutaneous Endoscopic Gastrostomy Tray) Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT Dated: December 22, 1998 Received: December 30, 1998 Dear Mr. Schlakman: 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. However, you are responsible to determine that the medical devices you use as components in the tray have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning {1}------------------------------------------------ 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 proced to the market. If you desire specific advice for your device on the 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 regulation 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, CAPT Daniel G. Schultz, M.D. CAPT 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}------------------------------------------------ ## Exhibit IU ## 984628 510(k) NUMBER (IF KNOWN): DEVICE NAME: Moss P.E.G. Tray INDICATIONS FOR USE: The Moss P. E. G. Tray is used to place a tube through the abdominal wall and into the lumen of the stomach (and/or beyond) without open surgery. The procedure provides a channel for providing nourishment directly into the digestive system for patients who cannot swallow (e.g. after stroke). An independent channel can be suctioned to remove excess feedings, swallowed air, or other fluids that might distend the stomach and lead to vomiting. Sit (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number (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)