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 |