The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Resolut Regenerative Material.
| Device ID | K970884 |
| 510k Number | K970884 |
| Device Name: | RESOLUT REGENERATIVE MATERIAL |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff, AZ 86004 |
| Contact | Jacqueline Kalbach |
| Correspondent | Jacqueline Kalbach W.L. GORE & ASSOCIATES,INC 1500 NORTH FOURTH ST. Flagstaff, AZ 86004 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-10 |
| Decision Date | 1997-05-08 |
| Summary: | summary |