FDA 510(k) Application Details - K183385

Device Classification Name	Low Energy Direct Current Thermal Ablation System   More FDA Info for this Device
510(K) Number	K183385
Device Name	Low Energy Direct Current Thermal Ablation System
Applicant	Angiodynamics 26 Forest Street Marlborough, MA 01752 US Other 510(k) Applications for this Company
Contact	Troy Roberts Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	OAB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2018
Decision Date	06/18/2019
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