FDA 510(k) Application Details - K040940

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K040940
Device Name Bronchoscope (Flexible Or Rigid)
Applicant OLYMPUS CORPORATION
TWO CORPORATE CENTER DRIVE
MELVILLE, NY 11747-3157 US
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Contact TINA STEFFANIE-OAK
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 04/12/2004
Decision Date 04/19/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee EN - Ear, Nose, & Throat
Review Advisory Committee EN - Ear, Nose, & Throat
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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