Name: Predicase
Price: 199 USD

K-number	K043323
Device name	D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
Applicant	Dideco S.R.L.
Product code	DTZ
Device class	Class II
Decision date	Feb 1, 2005
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR

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