FDA 510(k) Application Details - K082175

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K082175
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	BIOPLATE, INC. 3643 LENAWEE AVE. LOS ANGELES, CA 90016-4310 US Other 510(k) Applications for this Company
Contact	JESUS T FARINAS 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	08/01/2008
Decision Date	08/13/2008
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