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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
Device Name PLASMATRODE SALINE SAFE TUR ELECTRODE
Applicant
Cook Ireland, Ltd.
O Halloran Rd.
National Technology Park
Limerick,  IE 000
Applicant Contact NORA O'CONNOR
Correspondent
Cook Ireland, Ltd.
O Halloran Rd.
National Technology Park
Limerick,  IE 000
Correspondent Contact NORA O'CONNOR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/05/2012
Decision Date 04/17/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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