The following data is part of a premarket notification filed by Replam Corp. with the FDA for Replam Hydroxyapatatite.
| Device ID | K822420 |
| 510k Number | K822420 |
| Device Name: | REPLAM HYDROXYAPATATITE |
| Classification | Syringe, Piston |
| Applicant | REPLAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-12 |
| Decision Date | 1982-09-28 |