FDA 510(k) Application Details - K192124

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K192124
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	US Medical Innovations, LLC 6930 Carroll Ave Takoma Park, MD 20912 US Other 510(k) Applications for this Company
Contact	David Hinds 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	08/06/2019
Decision Date	11/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review