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FDA 510(k) Application Details - K112148
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K112148
Device Name
Stimulator, Muscle, Powered
Applicant
VALMED, SA
AVE DE TOURBILLON 34
SION, VALAIS CH 1950 CH
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Contact
CARL MAGNELL
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Regulation Number
890.5850
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Classification Product Code
IPF
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More FDA Info for this Product Code
Date Received
07/27/2011
Decision Date
04/30/2012
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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