Name: Predicase
Price: 199 USD

K-number	K162613
Device name	Integrated Catch-up Freedom Syringe Driver Infusion System
Applicant	Repro-Med Systems, Inc. Dba Rms Medical Products
Product code	FRN
Device class	Class II
Decision date	Aug 31, 2017
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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Integrated Catch-up Freedom Syringe Driver Infusion System

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