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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 K223334
Device Name Sterile Hypodermic Needles for Single Use
Applicant
Zhejiang Kindly Medical Devices Co., Ltd.
#758, 5th Binhai Rd., Binhai Industrial Park
Longwan District
Wenzhou,  CN 325000
Applicant Contact Zhang Qian
Correspondent
Shanghai Mind-Link Business Consulting Co., Ltd.
Rm. A04, 14th Floor, No 699, Jiaozhou Rd., Jingan District
Shanghai,  CN 200040
Correspondent Contact Amy Li
Regulation Number880.5570
Classification Product Code
FMI  
Date Received11/01/2022
Decision Date 12/16/2022
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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