FDA 510(k) Application Details - K132137

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K132137
Device Name Stimulator, Muscle, Powered
Applicant METRON MEDICAL AUSTRALIA PTY LTD
57 ASTER AVE.
CARRUM DOWNS, VICTORIA 3201 AU
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Contact DAVID MITCHELL
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 07/11/2013
Decision Date 09/12/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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