The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Bio-a Fistula Plug.
| Device ID | K083266 |
| 510k Number | K083266 |
| Device Name: | GORE BIO-A FISTULA PLUG |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD. Elkton, MD 21921 |
| Contact | Barbara L Smith |
| Correspondent | Barbara L Smith W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD. Elkton, MD 21921 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-05 |
| Decision Date | 2009-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H373FP06163 | K083266 | 000 |