The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Bioblanket.
| Device ID | K041923 |
| 510k Number | K041923 |
| Device Name: | BIOBLANKET |
| 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 |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-16 |
| Decision Date | 2004-09-08 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOBLANKET 78514377 3298867 Dead/Cancelled |
Kensey Nash Corporation 2004-11-10 |
![]() BIOBLANKET 75155663 not registered Dead/Abandoned |
James W. Barnett, Jr 1996-08-26 |