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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 K202570
Device Name Insulin Syringe, Insulin Syringe with Safety Retractable
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 Code
FMI  
Date Received09/04/2020
Decision Date 07/02/2021
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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