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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
Device Name STERILE BLUNT FOR SINGLE USE
Original Applicant
SHANGHAI DOUBLE DOVE INDUSTRIAL CO., LTD
p.o. box 237-023
shanghai,  CN 200237
Original Contact diana hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received02/10/2012
Decision Date 10/18/2012
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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