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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Endoscopic Cytology Brush
510(k) Number K052279
Device Name COOK IRELAND ECHOBRUSH
Applicant
COOK IRELAND LTD
O'HALLORAN ROAD
NATIONAL TECHNOLOGICAL PARK
LIMERICK,  IE
Applicant Contact EMMETT DEVEREUX
Correspondent
COOK IRELAND LTD
O'HALLORAN ROAD
NATIONAL TECHNOLOGICAL PARK
LIMERICK,  IE
Correspondent Contact EMMETT DEVEREUX
Regulation Number876.1500
Classification Product Code
FDX  
Date Received08/22/2005
Decision Date 10/11/2005
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
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