The following data is part of a premarket notification filed by Collafirm Llc with the FDA for Bovine Pericardium Patch.
| Device ID | K141721 |
| 510k Number | K141721 |
| Device Name: | BOVINE PERICARDIUM PATCH |
| Classification | Mesh, Surgical |
| Applicant | COLLAFIRM LLC 7 Deer Park Drive Suite M-7 Monmouth Jct, NJ 08852 |
| Contact | Surendra P Batra |
| Correspondent | Surendra P Batra COLLAFIRM LLC 7 Deer Park Drive Suite M-7 Monmouth Jct, NJ 08852 |
| Product Code | FTM |
| Subsequent Product Code | OXB |
| Subsequent Product Code | OXE |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-25 |
| Decision Date | 2014-12-22 |
| Summary: | summary |