The following data is part of a premarket notification filed by W. L. Gore & Associates, Inc. with the FDA for Gore Bio-a Wound Matrix.
| Device ID | K132397 |
| 510k Number | K132397 |
| Device Name: | GORE BIO-A WOUND MATRIX |
| Classification | Dressing, Wound, Drug |
| Applicant | W. L. GORE & ASSOCIATES, INC. 301 AIRPORT RD. Elkton, MD 21921 |
| Contact | Barbara L Smith, Rac |
| Correspondent | Barbara L Smith, Rac W. L. GORE & ASSOCIATES, INC. 301 AIRPORT RD. Elkton, MD 21921 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-01 |
| Decision Date | 2014-05-07 |
| Summary: | summary |