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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name gastroscope and accessories, flexible/rigid
510(k) Number K032177
Device Name GASTROINTESTINAL VIDEOSCOPE XGIF-Q14OM, XGIF-2T140M COLONOVIDEOSCOPE XCF-Q14ML/I, XPCF-160AML/I
Applicant
OLYMPUS OPTO-ELECTRONICS CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Applicant Contact TINA STEFFANIE-OAK
Correspondent
OLYMPUS OPTO-ELECTRONICS CO., LTD.
TWO CORPORATE CENTER DR.
MELVILLE,  NY  11747 -3157
Correspondent Contact TINA STEFFANIE-OAK
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FDF  
Date Received07/16/2003
Decision Date 10/02/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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