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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stents, Drains And Dilators For The Biliary Ducts
510(k) Number K962925
Device Name OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
Applicant
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact BARRY E SANDS
Correspondent
Olympus America, Inc.
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact BARRY E SANDS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/29/1996
Decision Date 10/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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