The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials, Inc. with the FDA for Cem-ostetic Bone; Cemo-10g, Cemo-20g, Cemo-30g, Cemo-40g, Cemo-60g, Cem0-xxgc; Cemo-xyz202005p, Cemo-xyz20210p, Cemo-xyz.
| Device ID | K030266 |
| 510k Number | K030266 |
| Device Name: | CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-27 |
| Decision Date | 2003-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858418003843 | K030266 | 000 |
| 00858418003416 | K030266 | 000 |
| 00858418003423 | K030266 | 000 |
| 00858418003430 | K030266 | 000 |
| 00858418003447 | K030266 | 000 |
| 00858418003454 | K030266 | 000 |
| 00858418003461 | K030266 | 000 |
| 00858418003492 | K030266 | 000 |
| 00858418003508 | K030266 | 000 |
| 00858418003515 | K030266 | 000 |
| 00858418003522 | K030266 | 000 |
| 00858418003829 | K030266 | 000 |
| 00858418003409 | K030266 | 000 |