Name: Predicase
Price: 199 USD

K-number	K152834
Device name	Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10
Applicant	Colonplus Equipments & Speculums, S.L.
Product code	KPL
Device class	Class II
Decision date	Aug 10, 2016
Decision	Substantially Equivalent
Regulation	876.5220

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10

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