The following data is part of a premarket notification filed by Biomatlante with the FDA for Mbcp Gel.
Device ID | K060732 |
510k Number | K060732 |
Device Name: | MBCP GEL |
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 | 2006-03-20 |
Decision Date | 2006-06-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03700501813518 | K060732 | 000 |
03700501813501 | K060732 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MBCP GEL 76457653 3259022 Dead/Cancelled |
BIOMATLANTE 2002-10-04 |