FDA 510(k) Application Details - K110684

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K110684
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	VANDUZEN DBA MEDCAD 1201 RICHARDSON SUITE 280 RICHARDSON, TX 75080 US Other 510(k) Applications for this Company
Contact	DIANE RUTHERFORD Other 510(k) Applications for this Contact
Regulation Number	882.5330   More FDA Info for this Regulation Number
Classification Product Code	GXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/11/2011
Decision Date	06/24/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review