The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore-tex(r) Curved Surgicalmembrane.
| Device ID | K945899 |
| 510k Number | K945899 |
| Device Name: | GORE-TEX(R) CURVED SURGICALMEMBRANE |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LAND DOCK A P.O. BOX 900 Flagstaff, AZ 86002 -0900 |
| Contact | R L Pratt |
| Correspondent | R L Pratt W.L. GORE & ASSOCIATES,INC 3750 WEST KILTIE LAND DOCK A P.O. BOX 900 Flagstaff, AZ 86002 -0900 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-02 |
| Decision Date | 1995-02-13 |