FDA 510(k) Application Details - K980892

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K980892
Device Name Stimulator, Muscle, Powered
Applicant ALIVE, INC.
537 CUMMINS ST.
HONOLULU, HI 96814 US
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Contact KAI HANSJURGENS
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/09/1998
Decision Date 05/11/1998
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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