FDA 510(k) Application Details - K103738

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K103738
Device Name Stimulator, Muscle, Powered
Applicant ELECTRONIC WAVEFORM LABORATORY, INC.
16168 BEACH BLVD., SUITE 232
HUNTINGTON BEACH, CA 92647 US
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Contact RYAN P HEANEY
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 12/22/2010
Decision Date 06/01/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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