CARRASYN ORAL WOUND DRESSING

{0} FDA U.S. FOOD & DRUG ADMINISTRATION February 25, 2025 Carrington Laboratories, Inc. Annita Weidenbach Director, Regulatory Technical Affairs P.O. Box 569003 Dallas, Texas 75356 Re: K933741 Trade/Device Name: Carrasyn Oral Wound Dressing Regulatory Class: Unclassified Product Code: OLR Dear Annita Weidenbach: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 4, 1994. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code OLR. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter, please contact Michael Adjodha, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices, 301-796-6276, Michael.Adjodha@fda.hhs.gov. Sincerely, # MICHAEL E. ADJODHA -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} [LOGO] DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service MAY 4 1994 Food and Drug Administration 1390 Piccard Drive Rockville MD 20850 Ms. Annita Weidenbach Carrington Laboratories, Inc. P.O. Box 569003 Dallas, Texas 75356 Re: K933741 Carrasyn Oral Wound Dressing Regulatory Class: Unclassified Dated: April 20, 1994 Received: April 21, 1994 Dear Ms. Weidenbach: 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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations: 1. This device may not be labeled for use on third degree burns. 2. This device may not be labeled as having any accelerating effect on the rate of wound healing or epithelization. 3. This device may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin. 4. This device may not be labeled as a treatment or a cure for any type of wound. The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81). The general controls provisions of the Act include requirements for 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 00000 {2} Page 2 - Ms. Annita Weidenbach 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. 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 the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations. This letter immediately will allow you to begin marketing your device as described. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice on the labeling for your device please contact the Office of Compliance, Promotion and Advertising Policy Staff, (HFZ-326) at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number (800) 638-2041 or at (301) 443-6597. Sincerely yours, Philip J. Phillips Philip J. Phillips Acting Deputy Director Office of Device Evaluation Center for Devices and Radiological Health N