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FDA 510(k) Application Details - K040849
Device Classification Name
Stimulator, Muscle, Powered
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510(K) Number
K040849
Device Name
Stimulator, Muscle, Powered
Applicant
COLE & ASSOCIATES
70 W. MADISON ST.
SUITE 3300
CHICAGO, IL 60602 US
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Contact
RICHARD O WOOD
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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
04/01/2004
Decision Date
10/01/2004
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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