AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX

Prosthesis, Tracheal, Expandable

ALVEOLUS, INC.

The following data is part of a premarket notification filed by Alveolus, Inc. with the FDA for Aero Tracheobronchial Stent System, Model 90129-2xx.

Pre-market Notification Details

Device IDK062511
510k NumberK062511
Device Name:AERO TRACHEOBRONCHIAL STENT SYSTEM, MODEL 90129-2XX
ClassificationProsthesis, Tracheal, Expandable
Applicant ALVEOLUS, INC. 9013 PERIMETER WOODS DRIVE SUITE A Charlotte,  NC  28216
ContactDonald Canal
CorrespondentDonald Canal
ALVEOLUS, INC. 9013 PERIMETER WOODS DRIVE SUITE A Charlotte,  NC  28216
Product CodeJCT  
CFR Regulation Number878.3720 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-28
Decision Date2007-01-31
Summary:summary

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