The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Drapeable St/lt Regenerative Membrane.
| Device ID | K013346 |
| 510k Number | K013346 |
| Device Name: | GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | W.L. GORE & ASSOCIATES,INC 3450 KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 -0500 |
| Contact | Jacqueline Kalbach |
| Correspondent | Jacqueline Kalbach W.L. GORE & ASSOCIATES,INC 3450 KILTIE LN. P.O. BOX 500 Flagstaff, AZ 86002 -0500 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-09 |
| Decision Date | 2001-12-19 |
| Summary: | summary |