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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
Original Applicant
MEDICAL RESCUE EQUIPMENT HOLDING AS
postboks 186
porsgrunn,  NO 3901
Original Contact knut fangberget
Classification Product Code
LGZ  
Date Received03/22/2012
Decision Date 05/08/2012
Decision substantially equivalent (SE)
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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