FDA 510(k) Application Details - K181007

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K181007
Device Name	Marker, Radiographic, Implantable
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	878.4300   More FDA Info for this Regulation Number
Classification Product Code	NEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2018
Decision Date	08/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review