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FDA 510(k) Application Details - K093848
Device Classification Name
Plasma, Coagulation Control
More FDA Info for this Device
510(K) Number
K093848
Device Name
Plasma, Coagulation Control
Applicant
DADE BEHRING, INC.
500 GBC DR, MAILSTOP 514
NEWARK, DE 19714-6101 US
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Contact
RADAMES RIESGO
Other 510(k) Applications for this Contact
Regulation Number
864.5425
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Classification Product Code
GGN
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More FDA Info for this Product Code
Date Received
12/16/2009
Decision Date
12/20/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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