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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 K211728
Device Name Sterile hypodermic syringes for single use
Applicant
Jiangsu Kangyou Medical Instrument Co., Ltd.
Tangzhuang Yaotang Town
Jintan,  CN 213223
Applicant Contact Xiang Yao
Correspondent
Jiangsu Kangyou Medical Instrument Co., Ltd.
Tangzhuang Yaotang Town
Jintan,  CN 213223
Correspondent Contact Xiang Yao
Regulation Number880.5860
Classification Product Code
FMF  
Date Received06/04/2021
Decision Date 10/05/2021
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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