FDA 510(k) Application Details - K111986

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K111986
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant SURGICAL INNOVATIONS PLC
CLAYTON WOOD HOUSE,
6 CLAYTON WOOD BANK
LEEDS, WEST YORKSHIRE LS16 6ZQ GB
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Contact PAUL BIRTLES
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 07/13/2011
Decision Date 01/26/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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