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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K050578
Device Name COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
Applicant
Cook Ireland, Ltd.
O'Holloran Rd.
National Technological Park
Limerick,  IE
Applicant Contact EMMETT DEVEREUX
Correspondent
Cook Ireland, Ltd.
O'Holloran Rd.
National Technological Park
Limerick,  IE
Correspondent Contact EMMETT DEVEREUX
Regulation Number876.4300
Classification Product Code
KNS  
Date Received03/07/2005
Decision Date 04/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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