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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name needle, hypodermic, single lumen
510(k) Number K120420
Model BLUNT FILL NEEDLE, BLUNT PLASTIC CANNULA
Device Name STERILE BLUNT FOR SINGLE USE
Original Applicant
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
p.o. box 237-023
shanghai,  CH 200237
Original Contact diana hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/10/2012
Decision Date 10/18/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General Hospital
Review Advisory Committee General Hospital
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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