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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
510(k) Number K124055
Device Name T1040 AKA AURAWAVE
Applicant
ENDURANCE THERAPEUTICS
122B - FIRST STREET NE
DAUPHIN, MANITOBA,  CA R7N 1B5
Applicant Contact BRAD BREZDEN
Correspondent
ENDURANCE THERAPEUTICS
122B - FIRST STREET NE
DAUPHIN, MANITOBA,  CA R7N 1B5
Correspondent Contact BRAD BREZDEN
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   NGX   NYN  
Date Received12/31/2012
Decision Date 07/19/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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