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FDA 510(k) Application Details - K142173
Device Classification Name
Warmer, Irrigation Solution
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
LHC
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More FDA Info for this Product Code
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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