Name: Predicase
Price: 199 USD

K-number	K170900
Device name	DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories
Applicant	Intervene Group, Ltd.
Product code	FMF
Device class	Class II
Decision date	Nov 9, 2017
Decision	Substantially Equivalent
Regulation	880.5860

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories

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