The following data is part of a premarket notification filed by Biomatlante with the FDA for Tribone 80.
Device ID | K071121 |
510k Number | K071121 |
Device Name: | TRIBONE 80 |
Classification | Filler, Bone Void, Calcium Compound |
Applicant | BIOMATLANTE 5, RUE EDOUARD BELIN Vigneux De Bretagne, FR 44360 |
Contact | Adeline Filliatre |
Correspondent | Adeline Filliatre 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 | 2007-04-20 |
Decision Date | 2007-09-11 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRIBONE 80 76457654 2842341 Dead/Cancelled |
BIOMATLANTE 2002-10-04 |