FDA 510(k) Application Details - K012804

Device Classification Name	Orthosis, Cranial   More FDA Info for this Device
510(K) Number	K012804
Device Name	Orthosis, Cranial
Applicant	SCOTT E ALLEN CP 50 SOUTH 900 EAST #1 SALT LAKE CITY, UT 84102 US Other 510(k) Applications for this Company
Contact	SCOTT E ALLEN 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	08/21/2001
Decision Date	01/17/2002
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