FDA 510(k) Application Details - K223135

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K223135
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	Compal Electronics, Inc No. 581, Ruiguang Rd., Neihu District Taipei City 11492 TW Other 510(k) Applications for this Company
Contact	Casper Chen 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	10/03/2022
Decision Date	06/30/2023
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