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FDA 510(k) Application Details - K122449
Device Classification Name
Warmer, Thermal, Infusion Fluid
More FDA Info for this Device
510(K) Number
K122449
Device Name
Warmer, Thermal, Infusion Fluid
Applicant
ACACIA, INC.
785 CHALLENGER ST.
BREA, CA 92821 US
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Contact
FERGIE FERGUSON
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LGZ
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More FDA Info for this Product Code
Date Received
08/13/2012
Decision Date
06/13/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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