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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 K163160
Device Name Sterile Single-use Infusion Set
Applicant
Jiangxi Hongda Medical Equipment Group , Ltd.
39 S. Shengli Rd., Jinxian County
Nanchang,  CN 331700
Applicant Contact Xiaohua Yang
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
FPA  
Date Received11/10/2016
Decision Date 04/20/2017
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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