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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K093122
Device Name MBCP+
Applicant
Biomatlante
5, Rue Edouard Belin
Za Les Quatre Nations
Vigneux De Bretagne,  FR 44360
Applicant Contact JEANNE CHAMOUSSET-ROMAN
Correspondent
Biomatlante
5, Rue Edouard Belin
Za Les Quatre Nations
Vigneux De Bretagne,  FR 44360
Correspondent Contact JEANNE CHAMOUSSET-ROMAN
Regulation Number872.3930
Classification Product Code
LYC  
Date Received10/02/2009
Decision Date 03/15/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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