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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 K053213
Device Name BI-OSTETIC FOAM, CEM-OSTETIC FOAM, TRI-OSTETIC FOAM, GENEROS FOAM
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  
Date Received11/16/2005
Decision Date 07/06/2006
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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