FDA 510(k) Application Details - K970847

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K970847
Device Name Stimulator, Muscle, Powered
Applicant ARMSTRONG INDUSTRIES, INC.
801 JUPITER RD., SUITE 102
PLANO, TX 75074 US
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Contact JOHN P LANDINO
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/07/1997
Decision Date 09/10/1997
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 N
Expedited Review



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