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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anoscope And Accessories
510(k) Number K060623
Device Name SHORTSHOT SAEED HEMORRHOIDAL MULTI-BAND LIGATOR WITH TRIVIEW ANOSCOPE
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 Number876.1500
Classification Product Code
FER  
Subsequent Product Code
FHN  
Date Received03/08/2006
Decision Date 09/06/2006
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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