The following data is part of a premarket notification filed by Bio2 Technologies, Inc with the FDA for Bio2 Clm Bg Bioactive Scaffold.
| Device ID | K152589 |
| 510k Number | K152589 |
| Device Name: | Bio2 CLM BG Bioactive Scaffold |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Bio2 Technologies, Inc 12 R Cabot Road Woburn, MA 01801 |
| Contact | Janet Krevolin |
| Correspondent | Janet Krevolin Bio2 Technologies, Inc 12 R Cabot Road Woburn, MA 01801 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-10 |
| Decision Date | 2016-01-12 |
| Summary: | summary |