FDA 510(k) Application Details - DEN130034

Device Classification Name

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510(K) Number DEN130034
Device Name REWALK
Applicant ARGO MEDICAL TECHNOLOGIES, INC.
33 LOCKE DR.
SUITE 240
MARLBOROUGH, MA 01752 US
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Contact JOHN V HAMILTON
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Regulation Number

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Classification Product Code PHL
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Date Received 06/17/2013
Decision Date 06/26/2014
Decision DENG -
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status
Type Direct
Reviewed By Third Party N
Expedited Review



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