The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Gore Resolut Xt Regenerative Material.
| Device ID | K973594 |
| 510k Number | K973594 |
| Device Name: | GORE RESOLUT XT REGENERATIVE MATERIAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | John W Nicholson |
| Correspondent | John W Nicholson W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1997-12-17 |
| Summary: | summary |