FDA 510(k) Application Details - K963252

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K963252
Device Name Bronchoscope (Flexible Or Rigid)
Applicant BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact LISA M QUAGLIA
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 08/19/1996
Decision Date 09/20/1996
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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