FDA 510(k) Application Details - K141318

Device Classification Name	More FDA Info for this Device
510(K) Number	K141318
Device Name	CIANNA MEDICAL SGS SYSTEM
Applicant	CIANNA MEDICAL, INC. 6 JOURNEY, SUITE 125 ALISO VIJEO, CA 92656 US Other 510(k) Applications for this Company
Contact	GARY MONCNIK 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	05/20/2014
Decision Date	08/27/2014
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