FDA 510(k) Application Details - K122716

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K122716
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant COOK IRELAND LTD
O HALLORAN ROAD
NATIONAL TECHNOLOGY PARK
LIMERICK 000 IE
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Contact NORA O'CONNOR
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 09/05/2012
Decision Date 04/17/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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