FDA 510(k) Application Details - K192813

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K192813
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Neauvia North America, Inc 8480 Honeycutt Rd Raleigh, NC 27615 US Other 510(k) Applications for this Company
Contact	Misty Williams 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	10/01/2019
Decision Date	03/06/2020
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