FDA 510(k) Application Details - K962591

Device Classification Name	Device, Warning, Overload, External Limb, Powered   More FDA Info for this Device
510(K) Number	K962591
Device Name	Device, Warning, Overload, External Limb, Powered
Applicant	CLEVELAND MEDICAL DEVICES, INC. 11000 CEDAR AVE., SUITE 130 CLEVELAND, OH 44106 US Other 510(k) Applications for this Company
Contact	ROBERT N SCHMIDT 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	07/02/1996
Decision Date	12/04/1996
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