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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 K220941
Device Name HotDog Temperature Management System
Applicant
Augustine Temperature Management
7656 West 78th Street
Minneapolis,  MN  55439
Applicant Contact Garrett Augustine
Correspondent
Augustine Temperature Management
7656 West 78th Street
Minneapolis,  MN  55439
Correspondent Contact Garrett Augustine
Regulation Number870.5900
Classification Product Code
DWJ  
Subsequent Product Code
FLL  
Date Received03/31/2022
Decision Date 09/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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