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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 K950729
FOIA Releasable 510(k) K950729
Device Name OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP)
Applicant
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Applicant Contact BARRY SANDS
Correspondent
OLYMPUS AMERICA, INC.
4 NEVADA DR.
LAKE SUCCESS,  NY  11042 -1179
Correspondent Contact BARRY SANDS
Regulation Number876.1500
Classification Product Code
ODD  
Date Received02/16/1995
Decision Date 03/17/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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