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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Irrigation Solution
510(k) Number K142080
Device Name NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
Applicant
Ecolab, Inc.
370 Wabasha St. N.
Saint Paul,  MN  55102
Applicant Contact JENNIFER WILLNER
Correspondent
Ecolab, Inc.
370 Wabasha St. N.
Saint Paul,  MN  55102
Correspondent Contact JENNIFER WILLNER
Regulation Number890.5950
Classification Product Code
LHC  
Date Received07/31/2014
Decision Date 08/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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