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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, multipurpose for in vitro coagulation studies
510(k) Number K083842
Device Name ROTEM DELTA THROMBOELASTOMETRY SYSTEM
Applicant
PENTAPHARM GMBH
STAHLGRUBERRING 12
MUNICH,  DE D-81829
Applicant Contact VOLKER JOACHIM FRIEMERT
Correspondent
PENTAPHARM GMBH
STAHLGRUBERRING 12
MUNICH,  DE D-81829
Correspondent Contact VOLKER JOACHIM FRIEMERT
Regulation Number864.5425
Classification Product Code
JPA  
Subsequent Product Code
GGN  
Date Received12/24/2008
Decision Date 03/23/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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