FDA 510(k) Application Details - K120804

Device Classification Name	More FDA Info for this Device
510(K) Number	K120804
Device Name	CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM
Applicant	CIANNA MEDICAL 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	PBY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2012
Decision Date	02/04/2013
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