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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Low Dead Space Needle, Single Lumen, Hypodermic
510(k) Number K210444
Device Name EZ-Injec LDV Sterile Safety Needle
Applicant
Poonglim Pharmatech, Inc.
21, Jayumuyeok 1-Gil
Gunsan,  KR
Applicant Contact Cho Hee Min
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5570
Classification Product Code
QNS  
Date Received02/16/2021
Decision Date 02/16/2021
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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