Name: Predicase
Price: 199 USD

K-number	K232046
Device name	Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection
Applicant	Xeridiem Medical Devices, A Spectrum Plastics Group Company
Product code	PIF
Device class	Class II
Decision date	Oct 6, 2023
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection

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