SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE

Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)

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 Shiley Specialized,pediatric & Neonatal Trach.tube.

Pre-market Notification Details

Device IDK925615
510k NumberK925615
Device Name:SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
ClassificationTube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
ContactAmy Boucly
CorrespondentAmy Boucly
SORIN BIOMEDICA, FIAT, USA, INC. 17600 GILETTE AVE. Irvine,  CA  92713
Product CodeCBI  
CFR Regulation Number868.5740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-06
Decision Date1993-03-26

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