FDA 510(k) Application Details - K180189

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K180189
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Inmode MD Ltd. Tabor Building Shaar Yokneam Yoqneam Illt 2069200 IL Other 510(k) Applications for this Company
Contact	Amit Goren Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	GEI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/23/2018
Decision Date	06/01/2018
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