Name: Predicase
Price: 199 USD

K-number	K161141
Device name	ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT
Applicant	Pentaferte Italia S.R.L.
Product code	PNR
Device class	Class II
Decision date	Mar 22, 2017
Decision	Substantially Equivalent
Regulation	876.5980

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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ENFit Enteral Pump Syringes PENTA ENFit, ENFit Enteral Pump Syringes NUTRIFIT

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