The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials, Inc. with the FDA for B-genin, R-genin.
| Device ID | K113791 |
| 510k Number | K113791 |
| Device Name: | B-GENIN, 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 | 2011-12-22 |
| Decision Date | 2012-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816125022311 | K113791 | 000 |
| 00816125021994 | K113791 | 000 |
| 00816125021987 | K113791 | 000 |
| 00816125021970 | K113791 | 000 |
| 00816125021963 | K113791 | 000 |
| 00816125021956 | K113791 | 000 |
| 00816125021949 | K113791 | 000 |
| 00816125021932 | K113791 | 000 |
| 00816125021925 | K113791 | 000 |
| 00816125021918 | K113791 | 000 |
| 00816125021901 | K113791 | 000 |
| 00816125021895 | K113791 | 000 |
| 00816125021888 | K113791 | 000 |
| 00816125021871 | K113791 | 000 |
| 00816125021864 | K113791 | 000 |
| 00816125021857 | K113791 | 000 |
| 00816125021840 | K113791 | 000 |
| 00816125021833 | K113791 | 000 |
| 00816125022007 | K113791 | 000 |
| 00816125022120 | K113791 | 000 |
| 00816125022137 | K113791 | 000 |
| 00816125022304 | K113791 | 000 |
| 00816125022298 | K113791 | 000 |
| 00816125022281 | K113791 | 000 |
| 00816125022274 | K113791 | 000 |
| 00816125022267 | K113791 | 000 |
| 00816125022250 | K113791 | 000 |
| 00816125022243 | K113791 | 000 |
| 00816125022236 | K113791 | 000 |
| 00816125022229 | K113791 | 000 |
| 00816125022212 | K113791 | 000 |
| 00816125022205 | K113791 | 000 |
| 00816125022199 | K113791 | 000 |
| 00816125022182 | K113791 | 000 |
| 00816125022175 | K113791 | 000 |
| 00816125022168 | K113791 | 000 |
| 00816125022151 | K113791 | 000 |
| 00816125022144 | K113791 | 000 |
| 00816125021826 | K113791 | 000 |