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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K132553
Device Name U&U STERILE PISTON SYRINGE WITHOUT NEEDLE
Applicant
U&U Medical Technology Co, Ltd.
Dongzhou Village, Hengshanqiao Town
Changzhou, Jiangsu,  CN 213119
Applicant Contact XUEBO WANG
Correspondent
U&U Medical Technology Co, Ltd.
Dongzhou Village, Hengshanqiao Town
Changzhou, Jiangsu,  CN 213119
Correspondent Contact XUEBO WANG
Regulation Number880.5860
Classification Product Code
FMF  
Date Received08/14/2013
Decision Date 02/27/2014
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
Recalls CDRH Recalls
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