FDA 510(k) Application Details - K063193

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K063193
Device Name	Marker, Radiographic, Implantable
Applicant	CARBON MEDICAL TECHNOLOGIES, INC. 1290 HAMMOND RD. ST. PAUL, MN 55110 US Other 510(k) Applications for this Company
Contact	ROBERT W JOHNSON 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	10/20/2006
Decision Date	11/21/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review