FDA 510(k) Application Details - K122449

Device Classification Name Warmer, Thermal, Infusion Fluid

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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
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Regulation Number 000.0000

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Classification Product Code LGZ
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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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