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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 K170279
Device Name Disposable High Pressure Syringe
Applicant
Union Medical Shenzhen Co., Ltd.
Rm. 603, Bldg. 3, Fantasia Mic Plaza, Nanhai Ave.
Nanshan District
Shenzhen,  CN 518062
Applicant Contact Wenguo Zhang
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 Received01/30/2017
Decision Date 12/12/2017
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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