FDA 510(k) Application Details - K023445

Device Classification Name	Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K023445
Device Name	Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty
Applicant	PARALLAX MEDICAL, INC. 940 DISC DR. SCOTTS VALLEY, CA 95066-4544 US Other 510(k) Applications for this Company
Contact	LINDA BRADLEY Other 510(k) Applications for this Contact
Regulation Number	882.5300   More FDA Info for this Regulation Number
Classification Product Code	MYU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2002
Decision Date	03/11/2003
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