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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 K060243
Device Name OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13
Applicant
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -9058
Applicant Contact LAURA STORMS-TYLER
Correspondent
OLYMPUS MEDICAL SYSTEMS CORPORATION
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -9058
Correspondent Contact LAURA STORMS-TYLER
Regulation Number874.4680
Classification Product Code
EOQ  
Date Received01/31/2006
Decision Date 06/23/2006
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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