Name: Predicase
Price: 199 USD

K-number	K080340
Device name	COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG
Applicant	Novartis Nutrition Corp.
Product code	KNT
Device class	Class II
Decision date	Mar 5, 2008
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG

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