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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K053519
Device Name SAFETY SYRINGE
Applicant
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
2200 NORTHWESTERN AVE.
RACINE,  WI  53404
Applicant Contact GARY POND
Correspondent
WUXI YUSHOU MEDICAL APPLICANCES CO., LTD
2200 NORTHWESTERN AVE.
RACINE,  WI  53404
Correspondent Contact GARY POND
Regulation Number880.5860
Classification Product Code
MEG  
Date Received12/19/2005
Decision Date 08/11/2006
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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