FDA 510(k) Application Details - K984157

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K984157
Device Name Bronchoscope (Flexible Or Rigid)
Applicant WILSON-COOK MEDICAL, INC.
4900 BETHANIA STATION RD.
WINSTON-SALEM, NC 27105 US
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Contact PAULA JOYCE
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 11/19/1998
Decision Date 12/08/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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