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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bronchoscope (Flexible Or Rigid)
510(k) Number K023984
Device Name MODIFICATION TO OLYMPUS BRONCHOSCOPES BF-40 SERIES, BF-240 SERIES, AND BF-160 SERIES
Applicant
THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE,  NY  11747
Applicant Contact LAURA STORMS-TYLER
Correspondent
THE OLYMPUS OPTICAL CO.
TWO CORPORATE DR.
MELVILLE,  NY  11747
Correspondent Contact LAURA STORMS-TYLER
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received12/02/2002
Decision Date 01/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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