ULTRACELL ABSORBENT STICK

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle. AUG 2 4 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ultracell Medical Technologies, Inc. c/o Ms. Colleen Martin Quality Control Manager and Official Correspondent 183 Providence-New London Turnpike North Stonington, CT 06359 Re: 510(K) Number: K012196 Trade/Device Name: Absorbent Stick Regulation Number: CFR 21 886.4790 Regulatory Class: Class II Product Code: HOZ Dated: July 10, 2001 Received: July 13, 2001 Dear Ms. Martin: 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 enace in the Medical Device Amendments, or to devices that have been reclassified in encernance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, accordance with the provident of 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 oublish 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. {1}------------------------------------------------ ## Page 2 - Ms. Colleen Martin 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 nredicate 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) 594-6413. 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 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, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ 510(k) NUMBER (IF KNOWN): __ 012196 DEVICE NAME: Ultracell Absorbent Stick INDICATIONS FOR USE: Used during surgery to protect delicate tissue from trauma, absorb fluid and act as a filter to aspirate. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | X | |----------------------|---| | (per 21 CFR 801.109) | | OR Over- (C 12-The-Counter-Use : Optional Format 1-2-96) Daniel W.C. Brown Ph.D. (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number _012196