FDA 510(k) Application Details - K240297

Device Classification Name	Low Energy Direct Current Thermal Ablation System   More FDA Info for this Device
510(K) Number	K240297
Device Name	Low Energy Direct Current Thermal Ablation System
Applicant	US Medical Innovations, LLC 6930 Carroll Ave. 10th Floor, Ste 1000 Tacoma Park, MD 20912 US Other 510(k) Applications for this Company
Contact	Jerome Canady 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	02/01/2024
Decision Date	05/03/2024
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