The following data is part of a premarket notification filed by Carbomedics, Inc. with the FDA for Hydroxylapatite.
| Device ID | K811101 |
| 510k Number | K811101 |
| Device Name: | HYDROXYLAPATITE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CARBOMEDICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-21 |
| Decision Date | 1981-11-20 |