FDA 510(k) Application Details - K181955

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

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510(K) Number K181955
Device Name Stimulator, Muscle, Powered, For Muscle Conditioning
Applicant Medical Cables, S.L.
Duque de la Victoria 6, 1
Malaga 29015 ES
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Contact Jose Fuertes Pena
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Regulation Number 890.5850

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Classification Product Code NGX
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Date Received 07/23/2018
Decision Date 02/12/2019
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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