The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Bioblanket Surgical Mesh.
| Device ID | K043259 |
| 510k Number | K043259 |
| Device Name: | BIOBLANKET SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | KENSEY NASH CORP. 55 EAST UWCHLAN AVE. Exton, PA 19341 |
| Contact | Deborah Racioppi |
| Correspondent | Deborah Racioppi KENSEY NASH CORP. 55 EAST UWCHLAN AVE. 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-24 |
| Decision Date | 2005-08-15 |
| Summary: | summary |