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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 K152410
Device Name Top Fine Pen Needle
Applicant
Medexel Co.,Ltd
252, Geumgwangosan-Ro, Guemgwang-Myeon
Anseong-Si,  KR 17535
Applicant Contact CHA DONG IK
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/26/2015
Decision Date 02/02/2016
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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