The following data is part of a premarket notification filed by Brennen Medical, Llc with the FDA for Porcine Dermal Xenografts Porcine Dermal Matrix.
| Device ID | K113866 |
| 510k Number | K113866 |
| Device Name: | PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX |
| Classification | Dressing, Wound, Collagen |
| 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 | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-03-23 |
| Summary: | summary |