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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 K033333
Device Name SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
Applicant
Aomori Olympus Co., Ltd.
2 Corporate Center Dr.
Melville,  NY  11747
Applicant Contact TINA STEFFANIE-OAK
Correspondent
Aomori Olympus Co., Ltd.
2 Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact TINA STEFFANIE-OAK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received10/16/2003
Decision Date 11/14/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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