X-REPAIR
Mesh, Surgical, Polymeric
SYNTHASOME
The following data is part of a premarket notification filed by Synthasome with the FDA for X-repair.
Pre-market Notification Details
| Device ID | K141394 |
| 510k Number | K141394 |
| Device Name: | X-REPAIR |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | SYNTHASOME 3030 BUNKER HILL STREET, SUITE 308 San Diego, CA 92109 |
| Contact | Anthony Ratcliffe |
| Correspondent | Anthony Ratcliffe SYNTHASOME 3030 BUNKER HILL STREET, 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 | 2014-05-28 |
| Decision Date | 2014-08-06 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B05500930 | K141394 | 000 |
| B055009 | K141394 | 000 |
Trademark Results [X-REPAIR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 X-REPAIR 78740382 3716984 Live/Registered |
Synthasome, Inc. 2005-10-25 |
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