The following data is part of a premarket notification filed by Replam Corp. with the FDA for Replam Hydroxyapatite.
| Device ID | K830304 |
| 510k Number | K830304 |
| Device Name: | REPLAM HYDROXYAPATITE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | REPLAM CORP. 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 | 1983-01-28 |
| Decision Date | 1983-04-06 |