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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, thermal regulating
510(k) Number K121720
Device Name WELKINS EMT/ICU TEMPERATURE MANAGERMENT SYSTEM
Original Applicant
WELKINS, LLC
1430 blue oaks blvd
suite 250
roseville,  CA  95747
Original Contact christopher blodgett
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received06/12/2012
Decision Date 08/20/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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