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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
Other 510(k) Applications for this Device
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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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