FDA 510(k) Application Details - DEN980001

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	DEN980001
Device Name	Orthosis, Cranial
Applicant	CRANIAL TECHNOLOGIES, INC. 1331 NORTH 7TH ST., SUITE 170 PHOENIX, AZ 85006 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	03/31/1998
Decision Date	05/29/1998
Decision	DENG -
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status
Type	Post-NSE
Reviewed By Third Party	N
Expedited Review