FDA 510(k) Application Details - K022175

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K022175
Device Name Stimulator, Muscle, Powered
Applicant VALMED CORP.
5080 NORTH OCEAN DRIVE 1A
SINGER ISLAND, FL 33404 US
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Contact GUY POITOUT
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 07/03/2002
Decision Date 09/09/2002
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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