FDA 510(k) Application Details - K050220

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K050220
Device Name Bronchoscope (Flexible Or Rigid)
Applicant OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE, NY 11747-9058 US
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Contact LAURA STORMS-TYLER
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Regulation Number 874.4680

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Classification Product Code EOQ
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Date Received 01/31/2005
Decision Date 02/10/2005
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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