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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Contamination Prevention Sheath
510(k) Number K060475
Device Name EVIS EXERA ULTRASONIC BRONCHOFIBERVIDEOSCOPE, OLYMPUS MODEL BF TYPE UC160F-OL8
Applicant
Olympus Medical Systems Corporation
Two Corporate Center Dr.
Melville,  NY  11747 -9058
Applicant Contact LAURA STORMS-TYLER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact NEIL E DEVINE
Regulation Number876.1500
Classification Product Code
ODB  
Subsequent Product Codes
EOQ   ITX  
Date Received02/23/2006
Decision Date 03/17/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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