The following data is part of a premarket notification filed by Curasan Ag with the FDA for Cerasorb M Ortho.
| Device ID | K040216 |
| 510k Number | K040216 |
| Device Name: | CERASORB M ORTHO |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | CURASAN AG 109 SHORE DRIVE Garner, NC 27529 |
| Contact | Eric Wiechert |
| Correspondent | Eric Wiechert CURASAN AG 109 SHORE DRIVE Garner, NC 27529 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-30 |
| Decision Date | 2004-03-26 |
| Summary: | summary |