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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 K984358
Device Name OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Applicant Contact LAURA STORMS-TYLER
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747 -3157
Correspondent Contact LAURA STORMS-TYLER
Regulation Number876.1500
Classification Product Code
FDS  
Date Received12/07/1998
Decision Date 09/17/1999
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
Recalls CDRH Recalls
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