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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 K124037
Device Name JUNG RIM SINGLE USE HYPODERMIC SYRINGE WITH NEEDLE
Applicant
JUNG RIM MEDICAL INDUSTRIAL CO., LTD
#593-81, SAGOK-RI, LWOL-MYEON
JINCHEON-GUN, CHUNGBUK,  KR 365-820
Applicant Contact KYU LEE
Correspondent
JUNG RIM MEDICAL INDUSTRIAL CO., LTD
#593-81, SAGOK-RI, LWOL-MYEON
JINCHEON-GUN, CHUNGBUK,  KR 365-820
Correspondent Contact KYU LEE
Regulation Number880.5860
Classification Product Code
FMF  
Subsequent Product Code
FMI  
Date Received12/28/2012
Decision Date 09/12/2013
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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