The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Fep Ringed Gore-tex Vascular Graft.
| Device ID | K934726 |
| 510k Number | K934726 |
| Device Name: | FEP RINGED GORE-TEX VASCULAR GRAFT |
| Classification | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter |
| Applicant | W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. POB 2200 Flagstaff, AZ 86003 -2200 |
| Contact | James D Lewis |
| Correspondent | James D Lewis W.L. GORE & ASSOCIATES,INC 1505 N. FOURTH ST. POB 2200 Flagstaff, AZ 86003 -2200 |
| Product Code | DYF |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-01 |
| Decision Date | 1993-12-08 |