The following data is part of a premarket notification filed by Biomatlante with the FDA for Mbcp+.
| Device ID | K093122 |
| 510k Number | K093122 |
| Device Name: | MBCP+ |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | BIOMATLANTE 5, RUE EDOUARD BELIN ZA LES QUATRE NATIONS Vigneux De Bretagne, FR 44360 |
| Contact | Jeanne Chamousset-roman |
| Correspondent | Jeanne Chamousset-roman BIOMATLANTE 5, RUE EDOUARD BELIN ZA LES QUATRE NATIONS Vigneux De Bretagne, FR 44360 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-02 |
| Decision Date | 2010-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700501812870 | K093122 | 000 |
| 03700501807197 | K093122 | 000 |
| 03700501813549 | K093122 | 000 |
| 03700501813495 | K093122 | 000 |
| 03700501813488 | K093122 | 000 |
| 03700501813457 | K093122 | 000 |
| 03700501813440 | K093122 | 000 |