The following data is part of a premarket notification filed by W.l. Gore & Associates, Inc. with the FDA for Gore Enform Biomaterial.
| Device ID | K173333 |
| 510k Number | K173333 |
| Device Name: | GORE ENFORM Biomaterial |
| Classification | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Applicant | W.L. Gore & Associates, Inc. 1505 N. Fourth Street Flagstaff, AZ 86004 |
| Contact | Barbara L Smith |
| Correspondent | Barbara L Smith W.L. Gore & Associates, Inc. 1505 N. Fourth Street Flagstaff, AZ 86004 |
| Product Code | OXF |
| Subsequent Product Code | OWT |
| Subsequent Product Code | OWZ |
| Subsequent Product Code | OXC |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2018-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00733132644728 | K173333 | 000 |
| 00733132644575 | K173333 | 000 |
| 00733132644582 | K173333 | 000 |
| 00733132644599 | K173333 | 000 |
| 00733132644605 | K173333 | 000 |
| 00733132644612 | K173333 | 000 |
| 00733132644629 | K173333 | 000 |
| 00733132644636 | K173333 | 000 |
| 00733132644643 | K173333 | 000 |
| 00733132644650 | K173333 | 000 |
| 00733132644667 | K173333 | 000 |
| 00733132644674 | K173333 | 000 |
| 00733132644681 | K173333 | 000 |
| 00733132644698 | K173333 | 000 |
| 00733132644704 | K173333 | 000 |
| 00733132644711 | K173333 | 000 |
| 00733132644568 | K173333 | 000 |