FDA 510(k) Application Details - K140437

Device Classification Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction   More FDA Info for this Device
510(K) Number	K140437
Device Name	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Applicant	PORIFEROUS, LLC. 535 PINE ROAD, SUITE 206 NEWNAN, GA 30263 US Other 510(k) Applications for this Company
Contact	AARON NOBLE 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	02/21/2014
Decision Date	06/13/2014
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