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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 K051695
Device Name MARROW PLUS (M+)
Applicant
Berkeley Advanced Biomaterials, Inc.
901 Grayson St., Suite 101
Berkeley,  CA  94710
Applicant Contact FRANCOIS GENIN
Correspondent
Berkeley Advanced Biomaterials, Inc.
901 Grayson St., Suite 101
Berkeley,  CA  94710
Correspondent Contact FRANCOIS GENIN
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
FMF  
Date Received06/23/2005
Decision Date 07/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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