Name: Predicase
Price: 199 USD

K-number	K182630
Device name	Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Applicant	Insulet Corporation
Product code	LZG
Device class	Class II
Decision date	Jan 8, 2019
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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Omnipod Insulin Management System, Omnipod DASH Insulin Management System

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