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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 Piston Syringe
510(k) Number K221860
Device Name PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe
Applicant
Poonglim Pharmatech, Inc.
21, Jayumuyeok 1-Gil
Gunsan,  KR 54001
Applicant Contact Hee Min Cho
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5860
Classification Product Code
QNQ  
Subsequent Product Codes
FMI   QNS  
Date Received06/27/2022
Decision Date 09/15/2023
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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