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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Snare, Flexible
510(k) Number K050294
Device Name COOK IRELAND SONNET POLYPECTOMY SNARE
Applicant
COOK IRELAND LTD
O'HOLLORAN ROAD
NATIONAL TECHNOLOGICAL PARK
LIMERICK,  IE
Applicant Contact EMMETT DEVEREUX
Correspondent
COOK IRELAND LTD
O'HOLLORAN ROAD
NATIONAL TECHNOLOGICAL PARK
LIMERICK,  IE
Correspondent Contact EMMETT DEVEREUX
Regulation Number876.4300
Classification Product Code
FDI  
Date Received02/07/2005
Decision Date 03/31/2005
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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