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FDA 510(k) Application Details - K043060
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K043060
Device Name
Analyzer, Body Composition
Applicant
OMRON HEALTHCARE, INC.
3460 POINTE CREEK COURT #102
BONITA SPRINGS, FL 34134 US
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Contact
LARRY LEPLEY
Other 510(k) Applications for this Contact
Regulation Number
870.2770
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Classification Product Code
MNW
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More FDA Info for this Product Code
Date Received
11/05/2004
Decision Date
01/19/2005
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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