FDA 510(k) Application Details - K191064

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K191064
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	New Deantronics Taiwan Ltd 12F., No.51, Sec.4, Chong Yang Rd., Tucheng Dist. New Taipei City 23675 TW Other 510(k) Applications for this Company
Contact	Jane Liu 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	04/22/2019
Decision Date	06/12/2019
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