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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 K130212
Device Name SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE
Applicant
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
215# XIGANG ROAD
DONGBEITANG
WUXI CITY, JINGSU,  CN 214191
Applicant Contact GARFIELD WANG
Correspondent
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
215# XIGANG ROAD
DONGBEITANG
WUXI CITY, JINGSU,  CN 214191
Correspondent Contact GARFIELD WANG
Regulation Number880.5570
Classification Product Code
FMI  
Subsequent Product Code
FMF  
Date Received01/29/2013
Decision Date 11/20/2013
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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