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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 K152323
Device Name Disposable Infusion Needle, Safelock Disposable Infusion Needle
Applicant
JIANGYIN CAINA TECHNOLOGY CO., LTD
NO. 2, TAIFU ROAD, HUASHI TOWN
JIANGYIN,  CN 214421
Applicant Contact JUN LU
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 Received08/17/2015
Decision Date 12/14/2015
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
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