The following data is part of a premarket notification filed by Brennen Medical, Inc. with the FDA for Mesh Matrix Wound Dressing.
| Device ID | K950281 |
| 510k Number | K950281 |
| Device Name: | MESH MATRIX WOUND DRESSING |
| Classification | Dressing, Wound, Collagen |
| Applicant | BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Jeffrey M Williams |
| Correspondent | Jeffrey M Williams BRENNEN MEDICAL, INC. 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-24 |
| Decision Date | 1995-04-13 |