The following data is part of a premarket notification filed by Brennen Medical, Llc with the FDA for Porcine Surgical Mesh; Dermal Matrix.
| Device ID | K081272 |
| 510k Number | K081272 |
| Device Name: | PORCINE SURGICAL MESH; DERMAL MATRIX |
| Classification | Mesh, Surgical |
| Applicant | BRENNEN MEDICAL, LLC 1290 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Kenneth B Herland |
| Correspondent | Kenneth B Herland BRENNEN MEDICAL, LLC 1290 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-05-05 |
| Decision Date | 2008-07-31 |
| Summary: | summary |