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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name electrosurgical, cutting & coagulation & accessories
510(k) Number K122716
Models PT-26XX-AC, WHERE XX CAN BE 45 OR 90, PT-26XX-OL, WHERE XX CAN BE 45 OR 90, PT-27XX-KS1, WHERE XX CAN BE 45 OR 90, PT-27XX-KS2, WHERE XX CAN BE 45 OR 90
Device Name PLASMATRODE SALINE SAFE TUR ELECTRODE
Original Applicant
COOK IRELAND LTD
o halloran road
national technology park
limerick,  IE 000
Original Contact nora o'connor
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/05/2012
Decision Date 04/17/2013
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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