The following data is part of a premarket notification filed by Kensey Nash Corporation Dba Dsm Biomedical with the FDA for Medeor Matrix Wound Dressing.
Device ID | K141738 |
510k Number | K141738 |
Device Name: | MEDEOR MATRIX WOUND DRESSING |
Classification | Dressing, Wound, Collagen |
Applicant | KENSEY NASH CORPORATION DBA DSM BIOMEDICAL 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
Contact | Brianna Jordan |
Correspondent | Brianna Jordan KENSEY NASH CORPORATION DBA DSM BIOMEDICAL 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 | 2014-06-27 |
Decision Date | 2015-02-17 |
Summary: | summary |