FDA 510(k) Application Details - K050595

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K050595
Device Name Stimulator, Muscle, Powered
Applicant MIDWEST DEVELOPMENT
S65 W35739 PIPER ROAD
EAGLE, WI 53119 US
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Contact STEPHEN GORSKI
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/08/2005
Decision Date 05/23/2005
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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