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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 K202437
Device Name Infusion Sets for Single Use
Jiangsu Suyun Medical Materials Co., Ltd.
No.18 Jinaqiao Road, Dapu Industrial Park,
Lianyungang Economic Development Zone
Lianyungang,  CN 222002
Applicant Contact Guangning Xu
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5440
Classification Product Code
Date Received08/25/2020
Decision Date 03/25/2022
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