FDA 510(k) Application Details - K062354

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K062354
Device Name Stimulator, Muscle, Powered
Applicant ENCORE MEDICAL, L.P.
4717 ADAMS ROAD
HIXSON, TN 37343 US
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Contact MICHAEL TREAS
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 08/14/2006
Decision Date 01/26/2007
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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