FDA 510(k) Application Details - K991313

Device Classification Name	Device, Warning, Overload, External Limb, Powered   More FDA Info for this Device
510(K) Number	K991313
Device Name	Device, Warning, Overload, External Limb, Powered
Applicant	ORTHOPEDIC TECHNOLOGY RESEARCH, INC. 4717 ADAMS RD. P.O. BOX 489 HIXSON, TN 37343 US Other 510(k) Applications for this Company
Contact	CHERYL G DYER Other 510(k) Applications for this Contact
Regulation Number	890.5575   More FDA Info for this Regulation Number
Classification Product Code	IRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/16/1999
Decision Date	06/23/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review