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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 K130230
Device Name STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES
Applicant
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
215# XIGANG ROAD
DONGBEITANG
wuxi city, jiangsu,  CN 214191
Applicant Contact garfield wang
Correspondent
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
215# XIGANG ROAD
DONGBEITANG
wuxi city, jiangsu,  CN 214191
Correspondent Contact garfield wang
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
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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