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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K252490
Device Name Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)
Applicant
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, # 278 Hangkong Rd.
Tianjin Pilot Free Trade Zone (Air Port Industrial Park)
Tianjin,  CN 300308
Applicant Contact Ningning Wang
Correspondent
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, # 278 Hangkong Rd.
Tianjin Pilot Free Trade Zone (Air Port Industrial Park)
Tianjin,  CN 300308
Correspondent Contact Ningning Wang
Regulation Number878.4850
Classification Product Code
FMK  
Date Received08/08/2025
Decision Date 02/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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