Name: Predicase
Price: 199 USD

K-number	K013915
Device name	D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER
Applicant	Dideco S.P.A.
Product code	DTZ
Device class	Class II
Decision date	Dec 27, 2001
Decision	Substantially Equivalent
Regulation	870.4350

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Source

View the full FDA submission: accessdata.fda.gov

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D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER

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