FDA 510(k) Application Details - K100862

Device Classification Name Stimulator, Muscle, Powered

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510(K) Number K100862
Device Name Stimulator, Muscle, Powered
Applicant PHYSIOMED ELEKTROMEDIZIN AG
HUTWEIDE 10
SCHNAITTACH/LAIPERSDORF D-91220 DE
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Contact BIRGIT SCHMID
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Regulation Number 890.5850

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Classification Product Code IPF
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Date Received 03/29/2010
Decision Date 04/21/2011
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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