The following data is part of a premarket notification filed by Synthasome, Inc. with the FDA for X-repairsl.
| Device ID | K141499 |
| 510k Number | K141499 |
| Device Name: | X-REPAIRSL |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-06 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B05502480SL | K141499 | 000 |
| B05502280SL | K141499 | 000 |
| B055021160SL | K141499 | 000 |
| B055020160SL | K141499 | 000 |
| B05502180 | K141499 | 000 |
| B05502120 | K141499 | 000 |
| B05502080 | K141499 | 000 |
| B05502020 | K141499 | 000 |