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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 K213183
Device Name Safety Insulin Pen Needles
Applicant
Zhejiang Kindly Medical Devices Co., Ltd.
#758, 5th Binhai Rd.
Binhai Industrial Park, Longwan District
Wenzhou,  CN 325025
Applicant Contact Yong Zhang
Correspondent
Shanghai Mind-Link Business Consulting Co., Ltd.
Rm. 8208, Second Floor, No 1399, Jiangyue Rd.
Minhang District
Shanghai,  CN 201114
Correspondent Contact Alice Huang
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/29/2021
Decision Date 10/14/2022
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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