LUNGPOINT PROCEDURE PLANNING

System, Image Processing, Radiological

BRONCUS TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Broncus Technologies, Inc. with the FDA for Lungpoint Procedure Planning.

Pre-market Notification Details

Device IDK093423
510k NumberK093423
Device Name:LUNGPOINT PROCEDURE PLANNING
ClassificationSystem, Image Processing, Radiological
Applicant BRONCUS TECHNOLOGIES, INC. 1400N SHORELINE BLVD. BLDG. A, SUITE 8 Mountain View,  CA  94043
ContactNancy Isaac
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-11-03
Decision Date2009-11-17
Summary:summary

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