The following data is part of a premarket notification filed by Kensey Nash Corp. with the FDA for Medeor Matrix, Models 30010-xx (hydrated); 30020-xx (dry).
| Device ID | K091499 |
| 510k Number | K091499 |
| Device Name: | MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) |
| Classification | Mesh, Surgical |
| Applicant | KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Contact | Alyssa Schwartz |
| Correspondent | Alyssa Schwartz KENSEY NASH CORP. 735 PENNSYLVANIA DRIVE Exton, PA 19341 |
| Product Code | FTM |
| Subsequent Product Code | OWY |
| Subsequent Product Code | OXB |
| Subsequent Product Code | OXE |
| Subsequent Product Code | OXH |
| Subsequent Product Code | PAJ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-21 |
| Decision Date | 2009-10-22 |
| Summary: | summary |