FDA 510(k) Application Details - K020088

Device Classification Name	Plate, Cranioplasty, Preformed, Non-Alterable   More FDA Info for this Device
510(K) Number	K020088
Device Name	Plate, Cranioplasty, Preformed, Non-Alterable
Applicant	BIOPLATE, INC. 6911 MELROSE AVE. LOS ANGELES, CA 90038 US Other 510(k) Applications for this Company
Contact	CAROL E JONES 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	01/10/2002
Decision Date	02/08/2002
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