Name: Predicase
Price: 199 USD

K-number	K061031
Device name	D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
Applicant	Sorin Group Italia S.R.L.
Product code	DTZ
Device class	Class II
Decision date	Jun 2, 2006
Decision	Substantially Equivalent
Regulation	870.4350

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View the full FDA submission: accessdata.fda.gov

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D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W

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