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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 K223313
Device Name Disposable Safety Lancets
Applicant
Huaian Hening Medical Instruments Co., Ltd.
# 6 W. Hongdou Rd. Economic Development Zone
Huaian,  CN
Applicant Contact Zhengcan Da
Correspondent
Huaian Hening Medical Instruments Co., Ltd.
# 6 W. Hongdou Rd. Economic Development Zone
Huaian,  CN
Correspondent Contact Zhengcan Da
Regulation Number878.4850
Classification Product Code
FMK  
Date Received10/28/2022
Decision Date 01/23/2023
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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