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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K043487
Device Name EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1
Applicant
Aizu Olympus Co., Ltd.
Two Corporate Center Dr.
Melville,  NY  11747 -9058
Applicant Contact LAURA STORMS-TYLER
Correspondent
Entela, Inc.
3033 Madison Ave., SE
Grand Rapids,  MI  49548
Correspondent Contact NEIL E DEVINE
Regulation Number876.1500
Classification Product Code
FDF  
Date Received12/17/2004
Decision Date 01/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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