Name: Predicase
Price: 199 USD

K-number	K131154
Device name	ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;
Applicant	Zevex, Inc.
Product code	LZH
Device class	Class II
Decision date	Feb 12, 2014
Decision	Substantially Equivalent
Regulation	880.5725

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Source

View the full FDA submission: accessdata.fda.gov

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ENTERALITE INFINITY SPIKE ENTERAL DELIVERY SET; ENTERALITE INFINITY 500 ML BAG ENTERAL DELIVERY SET;

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