Name: Predicase
Price: 199 USD

K-number	K130209
Device name	INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
Applicant	Sorin Group Italia S.R.L.
Product code	DTZ
Device class	Class II
Decision date	Feb 12, 2013
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED

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