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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K183665
Device Name Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
Applicant
Jiangsu Micsafe Medical Technology Co., Ltd.
Xituan Industrial Park, Dafeng District
Yancheng,  CN 224125
Applicant Contact Tony Yang
Correspondent
Jiangsu Micsafe Medical Technology Co., Ltd.
Xituan Industrial Park, Dafeng District
Yancheng,  CN 224125
Correspondent Contact Tony Yang
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Codes
FMF   FMI  
Date Received12/27/2018
Decision Date 09/06/2019
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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