The following data is part of a premarket notification filed by Cryolife, Inc. with the FDA for Propatch Soft Tissue Repair Matrix.
| Device ID | K101587 |
| 510k Number | K101587 |
| Device Name: | PROPATCH SOFT TISSUE REPAIR MATRIX |
| Classification | Mesh, Surgical |
| Applicant | CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Contact | Bryan Brosseau |
| Correspondent | Bryan Brosseau CRYOLIFE, INC. 1655 ROBERTS BLVD., N.W. Kennesaw, GA 30144 |
| Product Code | FTM |
| Subsequent Product Code | OWY |
| Subsequent Product Code | OXB |
| Subsequent Product Code | OXE |
| Subsequent Product Code | OXH |
| Subsequent Product Code | OXK |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2010-09-16 |
| Summary: | summary |