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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 K213013
Device Name Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe
Applicant
Jeil Tech Co., Ltd.
190, Maesilro, Sojeongmyeon
Sejong-Si,  KR 54001
Applicant Contact Chun-Gi Lee
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5860
Classification Product Code
QNQ  
Subsequent Product Code
FMI  
Date Received09/20/2021
Decision Date 09/19/2022
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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