FDA 510(k) Application Details - K172047

Device Classification Name	More FDA Info for this Device
510(K) Number	K172047
Device Name	Riva Star
Applicant	SDI Limited 3-13 Brunsdon Street Bayswater 3153 AU Other 510(k) Applications for this Company
Contact	Ray Cahill Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2017
Decision Date	04/11/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review