FDA 510(k) Application Details - K120922

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K120922
Device Name Stimulator, Muscle, Powered
Applicant SELECTIVEMED COMPONENTS INC.
8870 RAVELLO CT
NAPLES, FL 34114 US
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Contact DANIEL KAMM
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/27/2012
Decision Date 02/07/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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