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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 K241627
Device Name Safety Lancet (XXXV)
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 Ningning Wang
Correspondent
Tianjin Huahong Technology Co., Ltd.
A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free
Trade Zone(Air Port Industrial Park)
Tianjin,  CN 300308
Correspondent Contact Ningning Wang
Regulation Number878.4850
Classification Product Code
FMK  
Date Received06/06/2024
Decision Date 06/20/2024
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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