SORIN MONOLYRH INTEGRATED MEMBRANE LUNG

Oxygenator, Cardiopulmonary Bypass

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Sorin Monolyrh Integrated Membrane Lung.

Pre-market Notification Details

Device IDK922933
510k NumberK922933
Device Name:SORIN MONOLYRH INTEGRATED MEMBRANE LUNG
ClassificationOxygenator, Cardiopulmonary Bypass
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
ContactLori E Adels
CorrespondentLori E Adels
SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
Product CodeDTZ  
CFR Regulation Number870.4350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-18
Decision Date1992-11-30

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