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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 K223208
Device Name Safety Lancet
Applicant
Suzhou Zhenwu Medical Co., Ltd.
# 248, Chijiawan Rd., Wujiang District, Suzhou City,
Suzhou,  CN 215214
Applicant Contact Kai Xu
Correspondent
Shanghai Mind-Link Consulting Co., Ltd.
1399 Jiangyue Rd., Minhang
Shanghai,  CN 201114
Correspondent Contact Evan Hu
Regulation Number878.4850
Classification Product Code
FMK  
Date Received10/17/2022
Decision Date 02/10/2023
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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