The following data is part of a premarket notification filed by Kensey Nash Corporation with the FDA for Meso Wound Matrix.
| Device ID | K112888 |
| 510k Number | K112888 |
| Device Name: | MESO WOUND MATRIX |
| Classification | Dressing, Wound, Collagen |
| Applicant | KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Lori A Burns |
| Correspondent | Lori A Burns KENSEY NASH CORPORATION 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M26330052150 | K112888 | 000 |
| 00812337020480 | K112888 | 000 |
| 00812337020497 | K112888 | 000 |
| 00812337020503 | K112888 | 000 |
| 00812337020534 | K112888 | 000 |
| M26330052110 | K112888 | 000 |
| M26330052120 | K112888 | 000 |
| M26330052130 | K112888 | 000 |
| M26330052140 | K112888 | 000 |
| 00812337020473 | K112888 | 000 |