Name: Predicase
Price: 199 USD

K-number	K231549
Device name	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System
Applicant	Boston Scientific Corporation
Product code	OTN
Device class	Class II
Decision date	Jun 29, 2023
Decision	Substantially Equivalent
Regulation	878.3300

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Source

View the full FDA submission: accessdata.fda.gov

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Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System

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