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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Hypodermic, Single Lumen
510(k) Number K172938
Device Name Disposable Sterile Needle
Applicant
Jiangsu Caina Medical Co.,Ltd
#23, Huanxi Rd., Zhutang Town
Jiangyin,  CN 214425
Applicant Contact Jun Lu
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number880.5570
Classification Product Code
FMI  
Date Received09/26/2017
Decision Date 06/14/2018
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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