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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Syringes With Enteral Specific Connectors
510(k) Number K160855
Device Name U&U Enteral Syringe
Applicant
U&U MEDICAL TECHNOLOGY CO.,LTD
DONGZHOU VILLAGE, HENGYSHANQIAO
CHANGZHOU,  CN 213119
Applicant Contact BLACK WANG
Correspondent
U&U MEDICAL TECHNOLOGY CO.,LTD
DONGZHOU VILLAGE, HENGYSHANQIAO
CHANGZHOU,  CN 213119
Correspondent Contact BLACK WANG
Regulation Number876.5980
Classification Product Code
PNR  
Date Received03/28/2016
Decision Date 11/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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