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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 K231856
Device Name TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
Applicant
Medexel Co.,Ltd
252, Geumgwangosan-Ro, Geumgwang-Myeon
Anseong,  KR
Applicant Contact Juntaek Seo
Correspondent
Plusglobal
300, Atwood St.
Pittsburgh,  PA  15213
Correspondent Contact Peter Chung
Regulation Number880.5860
Classification Product Code
QNQ  
Date Received06/23/2023
Decision Date 03/15/2024
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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