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FDA 510(k) Application Details - K963271
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K963271
Device Name
Analyzer, Body Composition
Applicant
FUTREX, INC.
6 MONTGOMERY VILLAGE AVE.,
SUITE 620
GAITHERSBURG, MD 20879 US
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Contact
TORI TUNNELL
Other 510(k) Applications for this Contact
Regulation Number
870.2770
More FDA Info for this Regulation Number
Classification Product Code
MNW
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More FDA Info for this Product Code
Date Received
08/20/1996
Decision Date
08/19/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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