The following data is part of a premarket notification filed by Kensey Nash Corporation Dba Dsm Biomedical with the FDA for Meso Bilayer Surgical Mesh.
| Device ID | K132025 |
| 510k Number | K132025 |
| Device Name: | MESO BILAYER SURGICAL MESH |
| Classification | Mesh, Surgical |
| Applicant | KENSEY NASH CORPORATION DBA DSM BIOMEDICAL 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Susan Pileggi |
| Correspondent | Susan Pileggi KENSEY NASH CORPORATION DBA DSM BIOMEDICAL 735 PENNSYLVANIA DRIVE 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 | 2013-07-01 |
| Decision Date | 2013-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M26330060060 | K132025 | 000 |
| M26330060050 | K132025 | 000 |
| M26330060040 | K132025 | 000 |
| M26330060030 | K132025 | 000 |
| M26330060020 | K132025 | 000 |
| M26330060010 | K132025 | 000 |