FDA 510(k) Application Details - K080717

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K080717
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant EMCISION, LTD.
LIVER SURGERY, HAMMERSMITH
HOSPITAL CAMPUS, DU CANE RD.
LONDON, UK W12 OHS GB
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Contact NAGY HABIB
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 03/13/2008
Decision Date 03/27/2008
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 Y
Expedited Review



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