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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K032268
Device Name MBCP
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 Number888.3045
Classification Product Code
MQV  
Date Received07/23/2003
Decision Date 12/11/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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