The following data is part of a premarket notification filed by Ceramed Corp. with the FDA for Permamesh-d Hydroxylapatite Matrix.
| Device ID | K960354 |
| 510k Number | K960354 |
| Device Name: | PERMAMESH-D HYDROXYLAPATITE MATRIX |
| Classification | Implant, Malar |
| Applicant | CERAMED CORP. 12860 WEST CEDAR DR., STE. 110 Lakewood, CO 80228 |
| Contact | Barbara A Watson |
| Correspondent | Barbara A Watson CERAMED CORP. 12860 WEST CEDAR DR., STE. 110 Lakewood, CO 80228 |
| Product Code | LZK |
| CFR Regulation Number | 878.3550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-25 |
| Decision Date | 1996-03-20 |
| Summary: | summary |