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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 K181069
Device Name Disposable Insulin Pen Needle
Applicant
Zhejiang Kindly Medical Devices Co., Ltd.
#758, 5th Binhai Rd., Binhai Industrial Park
Longwan District
Wenzhou,  CN 325000
Applicant Contact Yong Zhang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received04/23/2018
Decision Date 08/28/2018
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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