The following data is part of a premarket notification filed by Berkeley Advanced Biomaterials with the FDA for Bi-ostetic Bioactive Glass Foam.
| Device ID | K170917 |
| 510k Number | K170917 |
| Device Name: | Bi-Ostetic Bioactive Glass Foam |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Berkeley Advanced Biomaterials 901 Grayson Street, Suite 101 Berkeley, CA 94710 |
| Contact | François Génin |
| Correspondent | François Génin Berkeley Advanced Biomaterials 901 Grayson Street, 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 | 2017-03-29 |
| Decision Date | 2017-10-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816125023653 | K170917 | 000 |
| 00816125023691 | K170917 | 000 |
| 00816125023806 | K170917 | 000 |
| 00816125023790 | K170917 | 000 |
| 00816125023783 | K170917 | 000 |
| 00816125023905 | K170917 | 000 |
| 00816125023899 | K170917 | 000 |
| 00816125023882 | K170917 | 000 |
| 00816125023875 | K170917 | 000 |
| 00816125024711 | K170917 | 000 |
| 00816125023509 | K170917 | 000 |
| 00816125023516 | K170917 | 000 |
| 00816125023646 | K170917 | 000 |
| 00816125023639 | K170917 | 000 |
| 00816125023622 | K170917 | 000 |
| 00816125023615 | K170917 | 000 |
| 00816125023608 | K170917 | 000 |
| 00816125023578 | K170917 | 000 |
| 00816125023561 | K170917 | 000 |
| 00816125023530 | K170917 | 000 |
| 00816125023523 | K170917 | 000 |
| 00816125024704 | K170917 | 000 |