FDA 510(k) Application Details - K112702

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K112702
Device Name Warmer, Thermal, Infusion Fluid
Applicant IMPERIAL SURGICAL LTD.
4 INNOVATION DRIVE
DUNDAS L9H 7P3 CA
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Contact KATHRYN RONALDS
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 09/16/2011
Decision Date 03/29/2012
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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