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FDA 510(k) Application Details - K062354
Device Classification Name
Stimulator, Muscle, Powered
More FDA Info for this Device
510(K) Number
K062354
Device Name
Stimulator, Muscle, Powered
Applicant
ENCORE MEDICAL, L.P.
4717 ADAMS ROAD
HIXSON, TN 37343 US
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Contact
MICHAEL TREAS
Other 510(k) Applications for this Contact
Regulation Number
890.5850
More FDA Info for this Regulation Number
Classification Product Code
IPF
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More FDA Info for this Product Code
Date Received
08/14/2006
Decision Date
01/26/2007
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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