YIELD TISSUE SAMPLER

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 Yield Tissue Sampler.

Pre-market Notification Details

Device IDK090853
510k NumberK090853
Device Name:YIELD TISSUE SAMPLER
ClassificationBronchoscope (flexible Or Rigid)
Applicant BRONCUS TECHNOLOGIES, INC. 1400 N. SHORELINE BLVD. BLDG A SUITE 8 Mountain Veiw,  CA  94043
ContactNancy Isaac
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeEOQ  
CFR Regulation Number874.4680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-03-30
Decision Date2009-04-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00856571007210 K090853 000
00856571007012 K090853 000

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