FDA 510(k) Application Details - K972055

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K972055
Device Name Stimulator, Muscle, Powered
Applicant MICROVAS SYSTEMS, INC.
400 N. LOOP 1604, SUITE 340
SAN ANTONIO, TX 78232 US
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Contact LARRY COHEN
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 06/02/1997
Decision Date 08/29/1997
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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