FDA 510(k) Application Details - K110769

Device Classification Name Warmer, Thermal, Infusion Fluid

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510(K) Number K110769
Device Name Warmer, Thermal, Infusion Fluid
Applicant STERIS Corporation
5960 HEISLEY
MENTOR, OH 44060 US
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Contact ROBERT F SULLIVAN
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Regulation Number 000.0000

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Classification Product Code LGZ
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Date Received 03/18/2011
Decision Date 06/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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