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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K042140
Device Name OLYMPUS BF TYPE UC160-OL8
Applicant
Olympus Corporation
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact TINA STEFFANIE-OAK
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DERWYN REUBER
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Codes
EOQ   FDS   ITX  
Date Received08/09/2004
Decision Date 08/18/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Radiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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