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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 K060732
Device Name MBCP GEL
Applicant
BIOMATLANTE
5, RUE EDOUARD BELIN
VIGNEUX DE BRETAGNE,  FR 44360
Applicant Contact MYRIAM VINCENT
Correspondent
BIOMATLANTE
5, RUE EDOUARD BELIN
VIGNEUX DE BRETAGNE,  FR 44360
Correspondent Contact MYRIAM VINCENT
Regulation Number872.3930
Classification Product Code
LYC  
Date Received03/20/2006
Decision Date 06/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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