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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 K031673
Device Name REFOBACIN -PALACOS G
Applicant
HERAEUS KULZER GMBH & CO. KG
GRUNER WEG 11
HANAU,  DE D-63450
Applicant Contact K.-D. KUHN
Correspondent
HERAEUS KULZER GMBH & CO. KG
GRUNER WEG 11
HANAU,  DE D-63450
Correspondent Contact K.-D. KUHN
Regulation Number888.3027
Classification Product Code
LOD  
Subsequent Product Code
MBB  
Date Received05/30/2003
Decision Date 05/25/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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