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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K162601
Device Name Infusion Set for Single Use
Applicant
Shinva Ande Healthcare Apparatus Co., Ltd.
#77 Development Zone N. Rd.,
Zibo,  CN 255086
Applicant Contact Xiaolei Tian
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Ying Xu
Regulation Number880.5440
Classification Product Code
FPA  
Date Received09/19/2016
Decision Date 05/31/2017
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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