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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, for pain relief
510(k) Number K121369
Device Name NEURODYN RUBY MUSCLE STIMULATOR, NEURODYN AUSSIE MUSCLE STIMULATOR
Original Applicant
IBRAMED EQUIPAMENTOS MEDICOS
18851 ne 29th ave 720
aventura,  FL  33180
Original Contact lilian llull
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
GZI   IPF   LIH  
Date Received05/07/2012
Decision Date 12/19/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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