Name: Predicase
Price: 199 USD

K-number	K231856
Device name	TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))
Applicant	Medexel Co.,Ltd
Product code	QNQ
Device class	Class II
Decision date	Mar 15, 2024
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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

Everything you need for a 510(k) submission. Nothing you don't.