PulmoVia Working Channel

Bronchoscope (flexible Or Rigid)

SANOVAS, INC.

The following data is part of a premarket notification filed by Sanovas, Inc. with the FDA for Pulmovia Working Channel.

Pre-market Notification Details

Device IDK150280
510k NumberK150280
Device Name:PulmoVia Working Channel
ClassificationBronchoscope (flexible Or Rigid)
Applicant SANOVAS, INC. 2597 Kerner Blvd San Rafael,  CA  94901
ContactRoy Morgan
CorrespondentCynthia Nolte
ICON Plc 62 Forest Street Suite 300 Marlborough,  MA  01752
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-05
Decision Date2015-06-11
Summary:summary

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