FDA 510(k) Application Details - K150190

Device Classification Name Warmer, Irrigation Solution

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510(K) Number K150190
Device Name Warmer, Irrigation Solution
Applicant Ecolab Inc.
370 Wabasha Street North
St. Paul, MN 55102-1390 US
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Contact Michelle Nivala
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Regulation Number 000.0000

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Classification Product Code LHC
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Date Received 01/27/2015
Decision Date 02/26/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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