FDA 510(k) Application Details - K133809

Device Classification Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction   More FDA Info for this Device
510(K) Number	K133809
Device Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Applicant	OXFORD PERFORMANCE MATERIALS 30 South Satellite Road South Windsor, CT 06074 US Other 510(k) Applications for this Company
Contact	LEIGH AYRES Other 510(k) Applications for this Contact
Regulation Number	878.3500   More FDA Info for this Regulation Number
Classification Product Code	KKY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2013
Decision Date	07/28/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review