The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials, Inc. with the FDA for Generos, Models Go-01g, Go-05g, Go-10g, Go-15g, Go-20g, Go-30g, Go-40g, Go-60g, Go-xyz Series, Go-dz Series.
| Device ID | K050666 |
| 510k Number | K050666 |
| Device Name: | GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES |
| 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 | 2005-03-14 |
| Decision Date | 2005-04-11 |
| Summary: | summary |