FDA 510(k) Application Details - K023572

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K023572
Device Name	Orthosis, Cranial
Applicant	REHABILITATION INSTITUTE,LOMA LINDA UNIVERSITY MED BANK ONE PLAZA, 10 S. DEARBORN CHICAGO, IL 60603 US Other 510(k) Applications for this Company
Contact	LYNN D FLEISHER Other 510(k) Applications for this Contact
Regulation Number	882.5970   More FDA Info for this Regulation Number
Classification Product Code	MVA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/24/2002
Decision Date	01/13/2003
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