The following data is part of a premarket notification filed by Mathys Corp. with the FDA for Ceros 80 (ha).
| Device ID | K900136 |
| 510k Number | K900136 |
| Device Name: | CEROS 80 (HA) |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | MATHYS CORP. 7 GREAT VALLEY PKWY. SUITE 223 Malvern, PA 19355 |
| Contact | Heinz Wick |
| Correspondent | Heinz Wick MATHYS CORP. 7 GREAT VALLEY PKWY. SUITE 223 Malvern, PA 19355 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-10 |
| Decision Date | 1991-01-29 |