FDA 510(k) Application Details - K980046

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K980046
Device Name Bronchoscope (Flexible Or Rigid)
Applicant BRONCUS TECHNOLOGIES, INC.
1400N SHORELINE BLVD.
BLDG. A, SUITE 8
MOUNTAIN VIEW, CA 94043 US
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Contact GLENDON E FRENCH
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 01/06/1998
Decision Date 05/01/1998
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 N
Expedited Review



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