FDA 510(k) Application Details - K103417

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K103417
Device Name	Marker, Radiographic, Implantable
Applicant	HALIFAX BIOMEDICAL, INC. 3 ELIZABETH PLACE LAKE HOPATCONG, NJ 07849 US Other 510(k) Applications for this Company
Contact	ROBERT A POGGIE, PHD 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	11/22/2010
Decision Date	06/28/2011
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