The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Bio-a Tissue Reinforcement.
| Device ID | K163217 |
| 510k Number | K163217 |
| Device Name: | GORE BIO-A Tissue Reinforcement |
| Classification | Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery |
| Applicant | W. L. GORE & ASSOCIATES, INC. 301 Airport Rd. PO BOX 1408 Elkton, MD 21922 -1408 |
| Contact | Barbara L Smith |
| Correspondent | Barbara L Smith W. L. GORE & ASSOCIATES, INC. 301 Airport Rd. PO BOX 1408 Elkton, MD 21922 -1408 |
| 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 | 2016-11-16 |
| Decision Date | 2017-02-10 |
| Summary: | summary |