The following data is part of a premarket notification filed by Synthasome, Inc. with the FDA for Synthasome X-repair.
| Device ID | K083307 |
| 510k Number | K083307 |
| Device Name: | SYNTHASOME X-REPAIR |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SYNTHASOME, INC. 3030 BUNKER HILL ST. SUITE 308 San Diego, CA 92109 |
| Contact | Anthony Ratcliffe |
| Correspondent | Anthony Ratcliffe SYNTHASOME, INC. 3030 BUNKER HILL ST. SUITE 308 San Diego, CA 92109 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-10 |
| Decision Date | 2009-03-27 |
| Summary: | summary |