FDA 510(k) Application Details - K020765

Device Classification Name Bronchoscope Accessory

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510(K) Number K020765
Device Name Bronchoscope Accessory
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PLACE
NATICK, MA 01760-1537 US
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Contact PAIGE SWEENEY
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Regulation Number 874.4680

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Classification Product Code KTI
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Date Received 03/08/2002
Decision Date 04/05/2002
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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