TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))— 510(k) K231856

Substantially Equivalent

Medexel Co.,Ltd

FDA 510(k) clearance K231856 for TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)), Substantially Equivalent on 2024-03-15. Applicant: Medexel Co.,Ltd. Device class: 2.

Clearance details

Applicant
Medexel Co.,Ltd
Product code
Code QNQ
Device class
Class 2
Regulation
21 CFR 880.5860
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Anseong, KR
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