Name: Predicase
Price: 199 USD

K-number	K242660
Device name	Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets
Applicant	Zevex, Inc.
Product code	FRN
Device class	Class II
Decision date	Oct 3, 2024
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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Curlin 8000 Ambulatory Infusion System; Enterprise Solution (ES) Software; Curlin 380-series Administration Sets

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