FDA 510(k) Application Details - K964423

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K964423
Device Name Stimulator, Muscle, Powered
Applicant AXIOM MANUFACTURING
717 LINGO DR. # 202
RICHARDSON, TX 75081 US
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Contact CHARLES OSBORNE
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 10/04/1996
Decision Date 01/24/1997
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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