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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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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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