The following data is part of a premarket notification filed by Medix Pharmaceuticals Americas, Inc. with the FDA for Biafine Wound Dressing Emulsion.
| Device ID | K964240 |
| 510k Number | K964240 |
| Device Name: | BIAFINE WOUND DRESSING EMULSION |
| Classification | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Applicant | MEDIX PHARMACEUTICALS AMERICAS, INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Contact | Wayne H Matelski |
| Correspondent | Wayne H Matelski MEDIX PHARMACEUTICALS AMERICAS, INC. 1050 CONNECTICUT AVENUE, N.W. Washington, DC 20036 |
| Product Code | MGQ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-24 |
| Decision Date | 1997-01-22 |