The following data is part of a premarket notification filed by Biomatlante with the FDA for Modification To Mbcp.
| Device ID | K043005 |
| 510k Number | K043005 |
| Device Name: | MODIFICATION TO MBCP |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | BIOMATLANTE 5, RUE EDOUARD BELIN Vigneux De Bretagne, FR 44360 |
| Contact | Myriam Vincent |
| Correspondent | Myriam Vincent BIOMATLANTE 5, RUE EDOUARD BELIN Vigneux De Bretagne, FR 44360 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-01 |
| Decision Date | 2005-05-03 |
| Summary: | summary |