The following data is part of a premarket notification filed by Biomatlante with the FDA for Mbcp.
| Device ID | K051885 |
| 510k Number | K051885 |
| Device Name: | MBCP |
| Classification | Bone Grafting Material, Synthetic |
| 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 | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-12 |
| Decision Date | 2005-09-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03700501812863 | K051885 | 000 |
| 03700501812818 | K051885 | 000 |
| 03700501812801 | K051885 | 000 |
| 03700501812795 | K051885 | 000 |
| 03700501812788 | K051885 | 000 |
| 03700501813426 | K051885 | 000 |
| 03700501813402 | K051885 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MBCP 76457651 2814613 Live/Registered |
BIOMATLANTE 2002-10-04 |