FDA 510(k) Application Details - K024165

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K024165
Device Name Bronchoscope (Flexible Or Rigid)
Applicant BISTECH, INC.
5 WHITCOMB AVE.
AYER, MA 01432 US
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Contact PAMELA PAPINEAU
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 12/17/2002
Decision Date 01/10/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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