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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Non-Coring (Huber) Needle
510(k) Number K200463
Device Name Huber Needle Infusion Set, Safety Huber Needle Infusion Set
Applicant
Jiangsu Caina Medical Co.,Ltd
# 23, Huanxi Rd. Zhutang Town
Jiangyin,  CN 214415
Applicant Contact Jianwei Pan
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5570
Classification Product Code
PTI  
Subsequent Product Code
FPA  
Date Received02/25/2020
Decision Date 04/07/2021
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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