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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 K050220
Device Name EVIS EXERA BRONCHOVIDEOSCOPE, OLYMPUS XBF-160Y3AC, XBF-1T160Y3AC,XBF-Q160Y2AC
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -9058
Applicant Contact LAURA STORMS-TYLER
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received01/31/2005
Decision Date 02/10/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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