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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Warmer, Thermal, Infusion Fluid
510(k) Number K120860
Device Name INFU BOX TYPE 0412A
Applicant
Medical Rescue Equipment Holding AS
Postboks 186
Porsgrunn,  NO 3901
Applicant Contact KNUT FANGBERGET
Correspondent
Medical Rescue Equipment Holding AS
Postboks 186
Porsgrunn,  NO 3901
Correspondent Contact KNUT FANGBERGET
Regulation Number880.5725
Classification Product Code
LGZ  
Date Received03/22/2012
Decision Date 05/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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