FDA 510(k) Application Details - K161458

Device Classification Name	More FDA Info for this Device
510(K) Number	K161458
Device Name	Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care
Applicant	Indiba USA Inc. 1717 Embarcadero Road Palo Alto, CA 94303 US Other 510(k) Applications for this Company
Contact	Carles Janer 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	05/26/2016
Decision Date	10/03/2016
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