FDA 510(k) Application Details - K080787

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K080787
Device Name Stimulator, Muscle, Powered
Applicant CURATRONIC, LTD.
20 HATA ' AS ST.
KFAR SABA 44425 IL
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Contact AHAVA STEIN
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/20/2008
Decision Date 04/17/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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