COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115

Bronchoscope (flexible Or Rigid)

BRONCUS TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Coagulation Electrode, Model 2000; Radiofrequency Generator, Model 20-115.

Pre-market Notification Details

Device IDK993900
510k NumberK993900
Device Name:COAGULATION ELECTRODE, MODEL 2000; RADIOFREQUENCY GENERATOR, MODEL 20-115
ClassificationBronchoscope (flexible Or Rigid)
Applicant BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View,  CA  94043
ContactJohn D'angelo
CorrespondentJohn D'angelo
BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View,  CA  94043
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-11-16
Decision Date2000-01-28
Summary:summary

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