FDA 510(k) Application Details - K161661

Device Classification Name	Electrosurgical, Cutting & Coagulation & Accessories   More FDA Info for this Device
510(K) Number	K161661
Device Name	Electrosurgical, Cutting & Coagulation & Accessories
Applicant	THERMI 8304 ESTERS BLVD STE 890 IRVING, TX 75063 US Other 510(k) Applications for this Company
Contact	Carrie Eddings 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	06/16/2016
Decision Date	08/12/2016
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