FDA 510(k) Application Details - K041146

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K041146
Device Name Stimulator, Muscle, Powered
Applicant CONTROL SOLUTIONS, INC.
508 WEST 5TH. AVE.
NAPERVILLE, IL 60563 US
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Contact BRETT WALACH
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 05/03/2004
Decision Date 06/08/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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