FDA 510(k) Application Details - K140926

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K140926
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant INMODE MD LTD.
20 HATA'AS STR., SUITE 102
KFAR SABA 44425 IL
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Contact AHAVA STEIN
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 04/11/2014
Decision Date 12/03/2014
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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