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