FDA 510(k) Application Details - K142173

Device Classification Name Warmer, Irrigation Solution

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510(K) Number K142173
Device Name Warmer, Irrigation Solution
Applicant ECOLAB, INC.
370 WABASHA STREET NORTH
ST.PAUL, MN 55102 US
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Contact JENNIFER WILLNER
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Regulation Number 000.0000

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Classification Product Code LHC
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Date Received 08/07/2014
Decision Date 12/30/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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