FDA 510(k) Application Details - K040018

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K040018
Device Name Bronchoscope (Flexible Or Rigid)
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact JAMES D MCMAHON
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 01/06/2004
Decision Date 01/20/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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