The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Depuy Orthotech Restore Orthobiologic Soft Tissue Implant.
| Device ID | K982330 |
| 510k Number | K982330 |
| Device Name: | DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT |
| Classification | Mesh, Surgical |
| Applicant | DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Contact | Cheryl K Hastings |
| Correspondent | Cheryl K Hastings DEPUY, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46581 -0988 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-02 |
| Decision Date | 1998-09-25 |
| Summary: | summary |