The following data is part of a premarket notification filed by Coors Biomedical Co. with the FDA for Additional Clinical Usages For Osteograf/ar & Ar+.
| Device ID | K863176 |
| 510k Number | K863176 |
| Device Name: | ADDITIONAL CLINICAL USAGES FOR OSTEOGRAF/AR & AR+ |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | COORS BIOMEDICAL CO. 12860 WEST CEDAR DR. SUITE 210 Lakewood, CO 80228 |
| Contact | Robert C Hale |
| Correspondent | Robert C Hale COORS BIOMEDICAL CO. 12860 WEST CEDAR DR. SUITE 210 Lakewood, CO 80228 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-18 |
| Decision Date | 1986-11-26 |