LYOCELL WOUND DRESSING/SURGICAL SPONGE

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white. Mr. Robert Feil President Courtaulds Fibers Inc. Highway 43, North Axis, Alabama 36505 SEP 1 9 1997 Re: K972458 > Trade Name: LYOCELL Wound Dressing/Surgical Sponge Regulatory Class: Unclassified Product Code: EFQ Dated: June 30, 1997 Received: July 1, 1997 Dear Mr. Feil: 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 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 publish 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 - Mr. Robert Feil 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 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) 594-4595. 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/dsmamain.html". Sincerely yours, Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a sequence of handwritten characters and numbers. The sequence starts with the letter 'K', followed by the numbers 9, 7, 2, 4, 5, and 8. The numbers are written in a simple, slightly irregular style, typical of handwriting. ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): K972458 LYOCELL Wound Dressing / Surgical Sponge Device Name: Indications For Use: LYOCELL Wound Dressing / Surgical Sponge is intended to be used for the local management of partial and full thickness wounds, including minor burns. LYOCELL is also intended to be used as a sponge for cleaning wounds and for absorbing excess body fluids or exudate. LYOCELL is also intended to be used to help control minor bleeding. (PLEASE DO NOT WRITE BELOW TINS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) | Concurrence of CDRH, Office of Device Evaluation (ODE) | | |--------------------------------------------------------|----------------------| | (Division Sign-Off) | | | Division of General Restorative Devices | | | 510(k) Number | 1972458 | | Prescription Use<br>(per 21 CFR 01.109) | X | | | OR | | | Over-The-Counter Use | (Optional Format 1-2-96)