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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name syringe, piston
510(k) Number K150758
Device Name Safety Disposable Insulin Syringe
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 Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
MEG  
Date Received03/23/2015
Decision Date 06/18/2015
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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