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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K092359
Device Name ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
Applicant
COOK IRELAND LTD
O'HALLORAN ROAD
NATIONAL TECHNOLOGY PARK
LIMERICK,  IE
Applicant Contact TRACY MORIARTY
Correspondent
COOK IRELAND LTD
O'HALLORAN ROAD
NATIONAL TECHNOLOGY PARK
LIMERICK,  IE
Correspondent Contact TRACY MORIARTY
Regulation Number876.1075
Classification Product Code
FCG  
Date Received08/04/2009
Decision Date 11/02/2009
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
Recalls CDRH Recalls
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