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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 K222376
Device Name Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA)
Applicant
Shandong Lianfa Medical Plastic Products Co. , Ltd.
# 1 Shuangshan Sanjian Rd., Zhangqiu
Jinan,  CN 250200
Applicant Contact Charles Shen
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Regulation Number878.4850
Classification Product Code
FMK  
Date Received08/05/2022
Decision Date 10/03/2022
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
Predetermined Change
Control Plan Authorized		 No
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