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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula
510(k) Number K011149
FOIA Releasable 510(k) K011149
Device Name DISPOSABLE BENDING CANNULA PR-233Q
Applicant
The Olympus Optical Co.
Endoscope Division
Two Corporate Center Dr.
Melville,  NY  11747
Applicant Contact LAURA STOMS-TYLER
Correspondent
The Olympus Optical Co.
Endoscope Division
Two Corporate Center Dr.
Melville,  NY  11747
Correspondent Contact LAURA STOMS-TYLER
Regulation Number876.1500
Classification Product Code
ODD  
Date Received04/16/2001
Decision Date 05/15/2001
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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