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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 K093195
Device Name ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
Applicant
COOK IRELAND LTD
O'HALLORAN ROAD
NATIONAL TECHNOLOGY PARK
LIMERICK,  IE
Applicant Contact Jacinta Kilmartin
Correspondent
COOK IRELAND LTD
O'HALLORAN ROAD
NATIONAL TECHNOLOGY PARK
LIMERICK,  IE
Correspondent Contact Jacinta Kilmartin
Regulation Number876.1075
Classification Product Code
FCG  
Date Received10/09/2009
Decision Date 01/21/2010
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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