The following data is part of a premarket notification filed by Kensey Nash Corporation with the FDA for Bioblanket Surgical Mesh.
| Device ID | K061030 |
| 510k Number | K061030 |
| Device Name: | BIOBLANKET SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Deborah Racioppi |
| Correspondent | Deborah Racioppi KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | FTM |
| Subsequent Product Code | OWY |
| Subsequent Product Code | OXB |
| Subsequent Product Code | OXE |
| Subsequent Product Code | OXH |
| Subsequent Product Code | PAI |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-14 |
| Decision Date | 2006-05-09 |
| Summary: | summary |