K-number	K210971
Device name	EnteraLoc Flow
Applicant	Vonco Products
Product code	PIF
Device class	Class II
Decision date	Aug 18, 2021
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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EnteraLoc Flow

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