The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Synecor Preperitoneal Biomaterial.
| Device ID | K163576 |
| 510k Number | K163576 |
| Device Name: | GORE SYNECOR Preperitoneal Biomaterial |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W. L. Gore & Associates, Inc. 1505 N. Fourth Street Flagstaff, AZ 86004 |
| Contact | Michael J. Titus |
| Correspondent | Michael J. Titus W. L. Gore & Associates, Inc. 1505 N. Fourth Street Flagstaff, AZ 86004 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-19 |
| Decision Date | 2017-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132638758 | K163576 | 000 |
| 00733132653706 | K163576 | 000 |
| 00733132653713 | K163576 | 000 |
| 00733132653720 | K163576 | 000 |
| 00733132653737 | K163576 | 000 |
| 00733132653744 | K163576 | 000 |
| 00733132638710 | K163576 | 000 |
| 00733132638727 | K163576 | 000 |
| 00733132638734 | K163576 | 000 |
| 00733132638741 | K163576 | 000 |
| 00733132653690 | K163576 | 000 |