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 | K191773 |
| 510k Number | K191773 |
| Device Name: | GORE BIO-A Tissue Reinforcement |
| Classification | Mesh, Surgical, Absorbable, Abdominal Hernia |
| 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 | OWT |
| Subsequent Product Code | OWZ |
| Subsequent Product Code | OXC |
| Subsequent Product Code | OXF |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-02 |
| Decision Date | 2019-07-31 |
| Summary: | summary |