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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Duodenoscope And Accessories, Flexible/Rigid
510(k) Number K980465
Device Name OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STORMS-TAYLER
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact LAURA STORMS-TAYLER
Regulation Number876.1500
Classification Product Code
FDT  
Date Received02/05/1998
Decision Date 04/21/1998
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
Predetermined Change
Control Plan Authorized		 No
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