The following data is part of a premarket notification filed by W.l Gore & Associates, Inc. with the FDA for Gore Synecor Biomaterial.
| Device ID | K152609 |
| 510k Number | K152609 |
| Device Name: | GORE SYNECOR Biomaterial |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L GORE & ASSOCIATES, INC. 301 AIRPORT ROAD Elkton, MD 21921 |
| Contact | Barbara L. Smith |
| Correspondent | Barbara L. Smith W.L GORE & ASSOCIATES, INC. 301 AIRPORT ROAD Elkton, MD 21921 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-14 |
| Decision Date | 2015-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132635382 | K152609 | 000 |
| 00733132635375 | K152609 | 000 |
| 00733132635368 | K152609 | 000 |
| 00733132635351 | K152609 | 000 |
| 00733132635344 | K152609 | 000 |