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FDA 510(k) Application Details - K060150
Device Classification Name
Device, Warning, Overload, External Limb, Powered
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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
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DORIT WINITZ
Other 510(k) Applications for this Contact
Regulation Number
890.5575
More FDA Info for this Regulation Number
Classification Product Code
IRN
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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
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