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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, intravascular, therapeutic, short-term less than 30 days
510(k) Number K142797
Device Name I.V. Catheter
Applicant
Jiangxi Sanxin Medtec Co., Ltd
No. 999, Fushan Road, Xiaolan Economic Development
Nanchang,  CN 330200
Applicant Contact Bingrong Liu
Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received09/29/2014
Decision Date 06/18/2015
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
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