The following data is part of a premarket notification filed by Kensey Nash Corporation Dba Dsm Biomedical with the FDA for Meso Tendon Matrix.
| Device ID | K133169 |
| 510k Number | K133169 |
| Device Name: | MESO TENDON MATRIX |
| Classification | Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon |
| 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 | OWY |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2013-12-20 |
| Summary: | summary |