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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 K143070
Device Name Disposable Safety Self-destructive Syringes, 5 ML
Applicant
Jiangsu Yile Medical Article Co., Ltd.
Sanhekou Development Zone
Changzhou City,  CN 213115
Applicant Contact Feng Xingyuan
Correspondent
International Regulatory Consulting
12226 Washington Lane
Echo,  AZ  85344
Correspondent Contact Charlie Mack
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMI  
Date Received10/27/2014
Decision Date 07/07/2015
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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