FDA 510(k) Application Details - K030669

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K030669
Device Name	Orthosis, Cranial
Applicant	NORTHEAST ORTHOTICS AND PROTHETICS, INC. 170 MACKLIN STREET CRANSTON, RI 02920 US Other 510(k) Applications for this Company
Contact	D. BARRY MCCOY 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	03/03/2003
Decision Date	07/18/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review