The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials, Inc. with the FDA for Cem-ostetic, Models Cemo-020o, Cemo-05p, Cemo-10p, Cemo-20p, And Cemo-30p.
| Device ID | K022622 |
| 510k Number | K022622 |
| Device Name: | CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BERKELEY ADVANCED BIOMATERIALS, INC. 1933 DAVIS ST. SUITE 307 San Leandro, CA 94577 |
| Contact | Francois Genin |
| Correspondent | Francois Genin BERKELEY ADVANCED BIOMATERIALS, INC. 1933 DAVIS ST. SUITE 307 San Leandro, CA 94577 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-07 |
| Decision Date | 2003-01-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816125023554 | K022622 | 000 |
| 00858418003027 | K022622 | 000 |
| 00858418003263 | K022622 | 000 |
| 00858418003270 | K022622 | 000 |
| 00858418003287 | K022622 | 000 |
| 00858418003485 | K022622 | 000 |
| 00858418003836 | K022622 | 000 |
| 00858418003942 | K022622 | 000 |
| 00858418003959 | K022622 | 000 |
| 00816125023394 | K022622 | 000 |
| 00816125023400 | K022622 | 000 |
| 00816125023547 | K022622 | 000 |
| 00816125024353 | K022622 | 000 |