FDA 510(k) Application Details - K010745

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K010745
Device Name Stimulator, Muscle, Powered
Applicant DAN MED, INC.
4 WEST DRY CREEK CIRCLE,
SUITE 260
DENVER, CO 80120 US
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Contact THOMAS SANDGAARD
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/13/2001
Decision Date 06/27/2001
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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