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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 K252861
Device Name Warming System
Applicant
Hangzhou Tappa Medical Technology Co., Ltd.
# 225#, Chutian Rd., Binjiang District, Hangzhou
Hangzhou,  CN
Applicant Contact Na Ban
Correspondent
Hangzhou Tappa Medical Technology Co., Ltd.
# 225#, Chutian Rd., Binjiang District, Hangzhou
Hangzhou,  CN
Correspondent Contact Na Ban
Regulation Number870.5900
Classification Product Code
DWJ  
Date Received09/09/2025
Decision Date 04/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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