FDA 510(k) Application Details - K132754

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K132754
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant ENERGIST, LTD.
2 PARK PAVILIONS, CLOS LLYN CWM
ENTERPRISE PARK
SWANSEA SA6 8QY GB
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Contact DARREN THOMAS
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 09/03/2013
Decision Date 12/12/2013
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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