FDA 510(k) Application Details - K060939

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K060939
Device Name Warmer, Thermal, Infusion Fluid
Applicant ARIZANT HEALTHCARE INC.
10393 WEST 70TH ST.
EDEN PRAIRIE, MN 55344 US
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Contact DAVID WESTLIN
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 04/06/2006
Decision Date 06/26/2006
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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