FDA 510(k) Application Details - K042385

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K042385
Device Name	Orthosis, Cranial
Applicant	CRANIAL TECHNOLOGIES, INC. 1395 WEST AUTO DR. TEMPE, AZ 85284 US Other 510(k) Applications for this Company
Contact	TIMOTHY R LITTLEFIELD 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	09/01/2004
Decision Date	12/17/2004
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