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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone cement
510(k) Number K123081
Device Name BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40
Applicant
AAP BIOMATERIALS GMBH & CO. KG
LAGERSTRASSE 11-15
DIEBURG,  DE 64807
Applicant Contact VOLKER STIRNAL
Correspondent
AAP BIOMATERIALS GMBH & CO. KG
LAGERSTRASSE 11-15
DIEBURG,  DE 64807
Correspondent Contact VOLKER STIRNAL
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received10/01/2012
Decision Date 03/07/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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