The following data is part of a premarket notification filed by Organogenesis, Inc. with the FDA for Graft Patch.
| Device ID | K970561 |
| 510k Number | K970561 |
| Device Name: | GRAFT PATCH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Contact | Diane E Minear, Rac |
| Correspondent | Diane E Minear, Rac ORGANOGENESIS, INC. 150 DAN RD. Canton, MA 02021 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-13 |
| Decision Date | 1997-08-01 |
| Summary: | summary |