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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 K172483
Device Name Kopac Sterile Needle
Applicant
Poonglim Pharmatech, Inc.
21, Jayumuyeok 1-Gil
Gunsan,  KR 54001
Applicant Contact Cho Hee Min
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5570
Classification Product Code
FMI  
Date Received08/16/2017
Decision Date 06/21/2018
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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