FDA 510(k) Application Details - K021594

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K021594
Device Name	Orthosis, Cranial
Applicant	CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC 2525 NORTH TENTH ST. #804 ARLINGTON, VA 22201 US Other 510(k) Applications for this Company
Contact	JOSEPH TERPENNING 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	05/15/2002
Decision Date	11/13/2003
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