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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
Applicant
IBRAMED EQUIPAMENTOS MEDICOS
18851 NE 29TH AVE 720
AVENTURA,  FL  33180
Applicant Contact LILIAN LLULL
Correspondent
IBRAMED EQUIPAMENTOS MEDICOS
18851 NE 29TH AVE 720
AVENTURA,  FL  33180
Correspondent 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 (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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