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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 K230866
Device Name HotDog Warming Mattress + Return Electrode
Applicant
Augustine Temperature Management, LLC
7656 W. 78th St.
Minneapolis,  MN  55439
Applicant Contact Garrett Augustine
Correspondent
Augustine Temperature Management
6581 City West Parkway
Eden Prairie,  MN  55344
Correspondent Contact Garrett Augustine
Regulation Number870.5900
Classification Product Code
DWJ  
Subsequent Product Code
GEI  
Date Received03/29/2023
Decision Date 06/29/2023
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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