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FDA 510(k) Application Details - K020478
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K020478
Device Name
Stimulator, Muscle, Powered
Applicant
ELECTROMEDICARIN, S.A.
1308 MORNINGSIDE PARK DR.
ALPHARETTA, GA 30022 US
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Contact
JAY MANSOUR
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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
02/13/2002
Decision Date
07/17/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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