The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Dualmesh Plus Biomaterial Gore Mycromesh Plus Biomaterial.
| Device ID | K063435 |
| 510k Number | K063435 |
| Device Name: | GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Contact | Michael Ivey |
| Correspondent | Michael Ivey W. L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LN. Flagstaff, AZ 86001 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-11-13 |
| Decision Date | 2006-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132601721 | K063435 | 000 |
| 00733132601226 | K063435 | 000 |
| 00733132601219 | K063435 | 000 |
| 00733132601202 | K063435 | 000 |
| 00733132601196 | K063435 | 000 |
| 00733132601189 | K063435 | 000 |
| 00733132601172 | K063435 | 000 |
| 00733132601165 | K063435 | 000 |
| 00733132601158 | K063435 | 000 |
| 00733132601141 | K063435 | 000 |
| 00733132601134 | K063435 | 000 |
| 00733132601127 | K063435 | 000 |
| 00733132601110 | K063435 | 000 |
| 00733132601103 | K063435 | 000 |
| 00733132601233 | K063435 | 000 |
| 00733132601240 | K063435 | 000 |
| 00733132601714 | K063435 | 000 |
| 00733132601707 | K063435 | 000 |
| 00733132601691 | K063435 | 000 |
| 00733132601684 | K063435 | 000 |
| 00733132601677 | K063435 | 000 |
| 00733132601660 | K063435 | 000 |
| 00733132601653 | K063435 | 000 |
| 00733132601646 | K063435 | 000 |
| 00733132601622 | K063435 | 000 |
| 00733132601615 | K063435 | 000 |
| 00733132601271 | K063435 | 000 |
| 00733132601264 | K063435 | 000 |
| 00733132601257 | K063435 | 000 |
| 00733132601097 | K063435 | 000 |