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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 EAST AURORA ROAD
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
Recalls CDRH Recalls
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