The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials, Inc. with the FDA for B-genin And R-genin.
| Device ID | K091912 |
| 510k Number | K091912 |
| Device Name: | B-GENIN AND R-GENIN |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BERKELEY ADVANCED BIOMATERIALS, INC. 901 GRAYSON ST., SUITE 101 Berkeley, CA 94710 |
| Contact | Francois Genin |
| Correspondent | Francois Genin BERKELEY ADVANCED BIOMATERIALS, INC. 901 GRAYSON ST., SUITE 101 Berkeley, CA 94710 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-25 |
| Decision Date | 2010-06-23 |
| Summary: | summary |