Name: Predicase
Price: 199 USD

K-number	K153506
Device name	Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit
Applicant	Consure Medical Pvt , Ltd.
Product code	KNT
Device class	Class II
Decision date	May 6, 2016
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida Stool Management Kit

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