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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K063742
Device Name RESONANCE METALLIC URETERAL STENT
Applicant
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick,  IE
Applicant Contact SINEAD BURKE
Correspondent
Cook Ireland, Ltd.
O' Halloran Rd., National Technology Park
Limerick,  IE
Correspondent Contact SINEAD BURKE
Regulation Number876.4620
Classification Product Code
FAD  
Date Received12/18/2006
Decision Date 05/08/2007
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
Predetermined Change
Control Plan Authorized		 No
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