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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multiple Use Blood Lancet For Single Patient Use Only
510(k) Number K262211
Device Name Lancet
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 Number878.4850
Classification Product Code
QRL  
Subsequent Product Code
QRK  
Date Received06/30/2026
Decision Date 07/22/2026
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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