The following data is part of a premarket notification filed by Ceramed Corp. with the FDA for Permamesh Hydroxylapatite Matrix.
| Device ID | K921468 |
| 510k Number | K921468 |
| Device Name: | PERMAMESH HYDROXYLAPATITE MATRIX |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | CERAMED CORP. 12860 WEST CEDAR DRIVE, SUITE 108 Lakewood, CO 80228 |
| Contact | Barbara A Watson |
| Correspondent | Barbara A Watson CERAMED CORP. 12860 WEST CEDAR DRIVE, SUITE 108 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 | 1992-03-27 |
| Decision Date | 1992-08-21 |