FDA 510(k) Application Details - K041215

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K041215
Device Name	Orthosis, Cranial
Applicant	OTTO BOCK HEALTH CARE, LP 2 CARLSON PWY. STE. 100 MINNEAPOLIS, MN 55447-4467 US Other 510(k) Applications for this Company
Contact	SHELLEY STOCKMAN 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	05/10/2004
Decision Date	09/09/2004
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