K982330 is an FDA 510(k) clearance for the DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT, a Mesh, Surgical (Class II — Special Controls, product code FTM), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 25, 1998, 85 days after receiving the submission on July 2, 1998. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3300.
| 510(k) Number | K982330 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 02, 1998 |
| Decision Date | September 25, 1998 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTM — Mesh, Surgical |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.3300 |