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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 K210914
Device Name Sterile Syringe for Single Use
Applicant
Jiangsu Suyun Medical Material Co., Ltd.
#18 Jinqiao Rd., Dapu Industrial Park
Lianyungang,  CN 222000
Applicant Contact Guangning Xu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5860
Classification Product Code
FMF  
Date Received03/29/2021
Decision Date 12/17/2021
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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