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FDA 510(k) Application Details - K124055
Device Classification Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
More FDA Info for this Device
510(K) Number
K124055
Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant
ENDURANCE THERAPEUTICS
122B - FIRST STREET NE
DAUPHIN, MANITOBA R7N 1B5 CA
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Contact
BRAD BREZDEN
Other 510(k) Applications for this Contact
Regulation Number
882.5890
More FDA Info for this Regulation Number
Classification Product Code
NUH
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More FDA Info for this Product Code
Date Received
12/31/2012
Decision Date
07/19/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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