FDA 510(k) Application Details - K032388

Device Classification Name	Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty   More FDA Info for this Device
510(K) Number	K032388
Device Name	Accessory,Barium Sulfate,Methyl Methacrylate For Cranioplasty
Applicant	Cardinal Health 1500 WAUKEGAN RD. MCGAW PARK, IL 60085 US Other 510(k) Applications for this Company
Contact	SHARON NICHOLS 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	08/04/2003
Decision Date	10/31/2003
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