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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 K152808
Device Name U&U Insulin Syringe with/without Safety Retractable Device
Applicant
U&U Medical Technology Co, Ltd.
Dongzhou Village
Hengshanqiao
Changzhou,  CN 213119
Applicant Contact Black Wang
Correspondent
U&U Medical Technology Co, Ltd.
Dongzhou Village
Hengshanqiao
Changzhou,  CN 213119
Correspondent Contact Black Wang
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMF  
Date Received09/28/2015
Decision Date 03/25/2016
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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