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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 K170014
Device Name High Pressure Tubing
Applicant
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
NO. 925 JINYUAN YI RD
SHANGHAI,  CN 201803
Applicant Contact Xu Jianhai
Correspondent
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD.
NO. 925 JINYUAN YI RD
SHANGHAI,  CN 201803
Correspondent Contact Jeffery Hui
Regulation Number870.1650
Classification Product Code
DXT  
Date Received01/03/2017
Decision Date 10/06/2017
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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