FDA 510(k) Application Details - K021588

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K021588
Device Name Stimulator, Muscle, Powered
Applicant BIOMEDICAL LIFE SYSTEMS, INC.
P.O. BOX 1360
VISTA, CA 92085-1360 US
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Contact RICHARD SAXON
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 05/14/2002
Decision Date 02/13/2003
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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