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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
Applicant
WELKINS, LLC
1430 BLUE OAKS BLVD
SUITE 250
ROSEVILLE,  CA  95747
Applicant Contact CHRISTOPHER BLODGETT
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
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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