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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 K242627
Device Name Safety Lancet
Applicant
Ningbo Medsun Medical Co., Ltd.
# 298 Huangjipu Rd., Jiangbei,
Ningbo,  CN 315031
Applicant Contact Liu Ping
Correspondent
Ningbo Medsun Medical Co., Ltd.
# 298 Huangjipu Rd., Jiangbei,
Ningbo,  CN 315031
Correspondent Contact Liu Ping
Regulation Number878.4850
Classification Product Code
FMK  
Date Received09/03/2024
Decision Date 10/30/2024
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
Predetermined Change
Control Plan Authorized		 No
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