Name: Predicase
Price: 199 USD

K-number	K171347
Device name	Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
Applicant	Xeridiem Medical Devices
Product code	PIF
Device class	Class II
Decision date	Jun 6, 2017
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Bi-Funnel and Tri-Funnel Gastrostomy Feeding Tubes with ENFit Connection, Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection

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