FDA 510(k) Application Details - K151296

Device Classification Name	More FDA Info for this Device
510(K) Number	K151296
Device Name	Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)
Applicant	BIOS S.R.L. VIA GUIDO ROSSA, 10/12 VIMODRONE I-20090 IT Other 510(k) Applications for this Company
Contact	RICCARDO PISATI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2015
Decision Date	11/19/2015
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