MBCP+

Bone Grafting Material, Synthetic

BIOMATLANTE

The following data is part of a premarket notification filed by Biomatlante with the FDA for Mbcp+.

Pre-market Notification Details

Device IDK093122
510k NumberK093122
Device Name:MBCP+
ClassificationBone Grafting Material, Synthetic
Applicant BIOMATLANTE 5, RUE EDOUARD BELIN ZA LES QUATRE NATIONS Vigneux De Bretagne,  FR 44360
ContactJeanne Chamousset-roman
CorrespondentJeanne Chamousset-roman
BIOMATLANTE 5, RUE EDOUARD BELIN ZA LES QUATRE NATIONS Vigneux De Bretagne,  FR 44360
Product CodeLYC  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-02
Decision Date2010-03-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03700501812870 K093122 000
03700501807197 K093122 000
03700501813549 K093122 000
03700501813495 K093122 000
03700501813488 K093122 000
03700501813457 K093122 000
03700501813440 K093122 000

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