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FDA 510(k) Application Details - K090853
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K090853
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
BRONCUS TECHNOLOGIES, INC.
1400 N. SHORELINE BLVD. BLDG A
SUITE 8
MOUNTAIN VEIW, CA 94043 US
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Contact
NANCY ISAAC
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Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
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More FDA Info for this Product Code
Date Received
03/30/2009
Decision Date
04/07/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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