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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector And Syringe, Angiographic
510(k) Number K172694
Device Name Sterile Disposable Syringes
Applicant
Shenyang Mastech Medical Device Co., Ltd.
Zhaojia Village, Qianjin St.
Dadong District
Shenyang,  CN 110165
Applicant Contact Liu Han
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number870.1650
Classification Product Code
DXT  
Date Received09/07/2017
Decision Date 07/06/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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