FDA 510(k) Application Details - K140467

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K140467
Device Name Stimulator, Muscle, Powered
Applicant EMSI
815 KING STREET STE 206
ALEXANDRIA, VA 22314 US
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Contact CHERITA JAMES
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 02/24/2014
Decision Date 10/07/2014
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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