510(k) Premarket Notification Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products 510(k) Premarket Notification FDA Home Medical Devices Databases - 510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC New Search Back To Search Results Device Classification Name Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic 510(k) Number K964240 Device Name BIAFINE WOUND DRESSING EMULSION Applicant Medix Pharmaceuticals Americas, Inc. 1050 Connecticut Ave., NW Washington, DC 20036 Applicant Contact WAYNE H MATELSKI Correspondent Medix Pharmaceuticals Americas, Inc. 1050 Connecticut Ave., NW Washington, DC 20036 Correspondent Contact WAYNE H MATELSKI Classification Product Code MGQ Date Received 10/24/1996 Decision Date 01/22/1997 Decision Substantially Equivalent (SESE) 510k Review Panel General & Plastic Surgery Statement Statement Type Traditional Reviewed by Third Party No Combination Product No Predetermined Change Control Plan Authorized No - - This website has been translated to Spanish from English, and is updated often. It is possible that some links will connect you to content only available in English or some of the words on the page will appear in English until translation has been completed (usually within 24 hours). We appreciate your patience with the translation process. In the case of any discrepancy in meaning, the English version is considered official. Thank you for visiting esp.fda.gov/tabaco. --> Links on this page: Page Last Updated: 08/03/2026 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and