FDA 510(k) Application Details - K121959

Device Classification Name Bronchoscope (Flexible Or Rigid)

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510(K) Number K121959
Device Name Bronchoscope (Flexible Or Rigid)
Applicant OLYMPUS MEDICAL SYSTEMS CORP.
3500 CORPORATE PARKWAY
PO BOX 610
CENTER VALLY, PA 18034 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 07/05/2012
Decision Date 01/10/2013
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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