FDA 510(k) Application Details - K111176

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K111176
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	OSTEOMED L.P. 3885 ARAPAHO RD. ADDISON, TX 75001 US Other 510(k) Applications for this Company
Contact	PIEDAD PENA Other 510(k) Applications for this Contact
Regulation Number	882.5320   More FDA Info for this Regulation Number
Classification Product Code	GWO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2011
Decision Date	08/15/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review