The following data is part of a premarket notification filed by Kensey Nash Corporation with the FDA for Kensey Nash Ecm Surgical Patch.
| Device ID | K094061 |
| 510k Number | K094061 |
| Device Name: | KENSEY NASH ECM SURGICAL PATCH |
| Classification | Mesh, Surgical |
| Applicant | KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Lori A Burns, Ms, Rac |
| Correspondent | Lori A Burns, Ms, Rac KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | FTM |
| Subsequent Product Code | OXE |
| Subsequent Product Code | OXH |
| Subsequent Product Code | PAG |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2010-05-18 |
| Summary: | summary |