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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 Rd., Dongbeitang
Wuxi,  CN 214191
Applicant Contact GARFIELD WANG
Correspondent
Wuxi Yushou Medical Applicances Co., Ltd.
# 215 Xigang Rd., Dongbeitang
Wuxi,  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
Predetermined Change
Control Plan Authorized		 No
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