FDA 510(k) Application Details - K023161

Device Classification Name	Device, Warning, Overload, External Limb, Powered   More FDA Info for this Device
510(K) Number	K023161
Device Name	Device, Warning, Overload, External Limb, Powered
Applicant	ANDANTE MEDICAL DEVICE, LTD. 117 AHUZAH ST. RA'ANANNA 43373 IL Other 510(k) Applications for this Company
Contact	ORLY MAOR 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	09/23/2002
Decision Date	12/10/2002
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