Name: Predicase
Price: 199 USD

K-number	K122844
Device name	INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
Applicant	Sorin Group Italia S.R.L.
Product code	DTZ
Device class	Class II
Decision date	Oct 17, 2012
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR

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