FDA 510(k) Application Details - K112148

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K112148
Device Name Stimulator, Muscle, Powered
Applicant VALMED, SA
AVE DE TOURBILLON 34
SION, VALAIS CH 1950 CH
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Contact CARL MAGNELL
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 07/27/2011
Decision Date 04/30/2012
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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