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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 K152522
Device Name ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes
Applicant
ECOLAB, INC.
370 WABASHA STREET NORTH
SAINT PAUL,  MN  55102
Applicant Contact Jennifer Willner
Correspondent
ECOLAB, INC.
370 WABASHA STREET NORTH
SAINT PAUL,  MN  55102
Correspondent Contact Jennifer Willner
Regulation Number890.5950
Classification Product Code
LHC  
Date Received09/03/2015
Decision Date 01/15/2016
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
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