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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 K112057
Device Name KDL SYRINGES AND NEEDLE
Original Applicant
SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO.,
p.o. box 237-023
shanghai,  CN 200237
Original Contact diana hong
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received07/19/2011
Decision Date 12/14/2011
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
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