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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 K220372
Device Name Heel Stick Safety Lancet (HHZ-II, HHZ-III)
Applicant
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free
Trade Zone(Air Port Industrial Park)
Tianjin,  CN 300308
Applicant Contact Yuan Ying
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd
Room 1308, Baohua International Plaza,West Guangzhong Road
555, Jingan District
Shanghai,  CN 200072
Correspondent Contact Stuart Situ
Regulation Number878.4850
Classification Product Code
FMK  
Date Received02/09/2022
Decision Date 05/17/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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