FDA 510(k) Application Details - K181071

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K181071
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Innoblative Designs, Inc. 4660 Ravenswood Avenue Chicago, IL 60640 US Other 510(k) Applications for this Company
Contact	Tyler Wanke 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	04/23/2018
Decision Date	01/16/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review