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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K260845
Device Name Huahong Sharps Container (HHR-I, HHR-II)
Applicant
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, # 278, Hangkong Rd., Tianjin Pilot Free Trade
Tianjin,  CN 300308
Applicant Contact Ningning Wang
Correspondent
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, # 278, Hangkong Rd., Tianjin Pilot Free Trade
Tianjin,  CN 300308
Correspondent Contact Ningning Wang
Regulation Number880.5570
Classification Product Code
MMK  
Date Received03/16/2026
Decision Date 08/05/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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