The following data is part of a premarket notification filed by W.l. Gore & Associates, Inc. with the FDA for Gore Resolut Regenerative Material, Gore Resolut Xt Regenerative Membrane, Gore Osseoquest Regenerative Membrane.
| Device ID | K051267 |
| 510k Number | K051267 |
| Device Name: | GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE |
| Classification | Barrier, Synthetic, Intraoral |
| Applicant | W.L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LANE, P.O.BOX 500 Flagstaff, AZ |
| Contact | Jacqueline Kalbach |
| Correspondent | Jacqueline Kalbach W.L. GORE & ASSOCIATES, INC. 3450 WEST KILTIE LANE, P.O.BOX 500 Flagstaff, AZ |
| Product Code | NPK |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-16 |
| Decision Date | 2005-06-15 |
| Summary: | summary |