FDA 510(k) Application Details - K121964

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K121964
Device Name	Marker, Radiographic, Implantable
Applicant	AUGMENIX , INC. 204 SECOND AVENUE LOWER LEVEL WALTHAM, MA 02451 US Other 510(k) Applications for this Company
Contact	Eric Ankerud 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	07/05/2012
Decision Date	01/23/2013
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