FDA 510(k) Application Details - K061914

Device Classification Name Stimulator, Muscle, Powered, For Muscle Conditioning

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510(K) Number K061914
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant SPORT-ELEC S.A.
ROUTE DE POUEN BP 35
BOURGTHEROULDE INFREVILLE 91400 FR
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Contact ARMELLE LAPRELLE
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 07/06/2006
Decision Date 07/26/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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