FDA 510(k) Application Details - K161507

Device Classification Name	More FDA Info for this Device
510(K) Number	K161507
Device Name	Cianna Medical SAVI Scout Reflector and SAVI Scout System
Applicant	CIANNA MEDICAL, INC. 6 JOURNEY SUITE 125 ALISO VIEJO, CA 92656 US Other 510(k) Applications for this Company
Contact	GARY MOCNIK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2016
Decision Date	07/29/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review