The following data is part of a premarket notification filed by Ceramed Corp. with the FDA for Osteograf/p Periodontal Hydroxylapatite, 40-60.
| Device ID | K891173 |
| 510k Number | K891173 |
| Device Name: | OSTEOGRAF/P PERIODONTAL HYDROXYLAPATITE, 40-60 |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CERAMED CORP. 12860 WEST CEDAR DRIVE, SUITE 108 Lakewood, CO 80228 |
| Contact | Kerry L Graf |
| Correspondent | Kerry L Graf CERAMED CORP. 12860 WEST CEDAR DRIVE, SUITE 108 Lakewood, CO 80228 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-06 |
| Decision Date | 1989-09-01 |