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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K152606
Device Name Jeesung Safety Syringe and Single Use Needles
Applicant
Jeesung Medical Co., Ltd.
54, Mujini 1-Gil, Daedeok-Gu
Daejeon,  KR 306-130
Applicant Contact Choi Yong Hyun
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5860
Classification Product Code
MEG  
Date Received09/11/2015
Decision Date 06/28/2016
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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