FDA 510(k) Application Details - K191878

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K191878
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Dex Surgical 3 Rue Des Petits Ruisseaux Verrieres Le Buisson 91370 FR Other 510(k) Applications for this Company
Contact	Guillaume Noury 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	07/15/2019
Decision Date	01/29/2021
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