FDA 510(k) Application Details - K131629

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K131629
Device Name Stimulator, Muscle, Powered
Applicant IBRAMED EQUIPAMENTOS MEDICOS
18851 NE 29TH AVE 720
AVENTURA, FL 33180 US
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Contact LILIAN LLULL
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 06/04/2013
Decision Date 11/26/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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