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FDA 510(k) Application Details - K011267
Device Classification Name
Bronchoscope (Flexible Or Rigid)
More FDA Info for this Device
510(K) Number
K011267
Device Name
Bronchoscope (Flexible Or Rigid)
Applicant
BRONCUS TECHNOLOGIES, INC.
1400N SHORELINE BLVD.
BLDG. A, SUITE 8
MOUNTAIN VIEW, CA 94043 US
Other 510(k) Applications for this Company
Contact
TIM R WILLIAMS
Other 510(k) Applications for this Contact
Regulation Number
874.4680
More FDA Info for this Regulation Number
Classification Product Code
EOQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/26/2001
Decision Date
05/08/2001
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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