FDA 510(k) Application Details - K112812

Device Classification Name	Plate, Cranioplasty, Preformed, Alterable   More FDA Info for this Device
510(K) Number	K112812
Device Name	Plate, Cranioplasty, Preformed, Alterable
Applicant	JEIL MEDICAL CORPORATION 5966 EXETER CIRCLE NORCROSS, GA 30071 US Other 510(k) Applications for this Company
Contact	PAUL SUMNER 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	09/27/2011
Decision Date	02/22/2012
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