FDA 510(k) Application Details - K060150

Device Classification Name	Device, Warning, Overload, External Limb, Powered   More FDA Info for this Device
510(K) Number	K060150
Device Name	Device, Warning, Overload, External Limb, Powered
Applicant	ANDANTE MEDICAL DEVICES LTD. 7 JABOTINSKY STREET (MOSHE AVIV TOWER) RAMAT GAN 52520 IL Other 510(k) Applications for this Company
Contact	DORIT WINITZ 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	01/20/2006
Decision Date	02/23/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review