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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K233037
Device Name Sterile Hypodermic Needles for Single Use
Applicant
Zhejiang Kindly Medical Device Co., Ltd.
758 Binhai 5th Ave., Binhai Industrial Park
Longwan
Wenzhou City,  CN 325025
Applicant Contact Zhang Qian
Correspondent
Shanghai Mind-Link Business Consulting Co., Ltd.
Rm. A08, Floor 14th, No 699, Jiaozhou Rd., Jingan District
Shanghai,  CN 201803
Correspondent Contact Amy Li
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/25/2023
Decision Date 12/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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