FDA 510(k) Application Details - K080376

Device Classification Name	Low Energy Direct Current Thermal Ablation System   More FDA Info for this Device
510(K) Number	K080376
Device Name	Low Energy Direct Current Thermal Ablation System
Applicant	ONCOBIONIC INCORPORATED 30211 AVENIDA DE LAS BANDERAS SUITE 200 RANCHO SANTA MARGARITA, CA 92688 US Other 510(k) Applications for this Company
Contact	PAUL MIKUS 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	02/12/2008
Decision Date	04/02/2008
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