FDA 510(k) Application Details - K052771

Device Classification Name	Orthosis, Limb Brace   More FDA Info for this Device
510(K) Number	K052771
Device Name	Orthosis, Limb Brace
Applicant	OTTO BOCK HEALTH CARE, LP 2 CARLSON PWY. STE. 100 MINNEAPOLIS, MN 55447-4467 US Other 510(k) Applications for this Company
Contact	BILL CLOVER Other 510(k) Applications for this Contact
Regulation Number	890.3475   More FDA Info for this Regulation Number
Classification Product Code	IQI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2005
Decision Date	05/03/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review