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FDA 510(k) Application Details - K011652
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K011652
Device Name
Analyzer, Body Composition
Applicant
OMRON HEALTHCARE, INC.
300 LAKEVIEW PKWY.
VERNON HILLS, IL 60061 US
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Contact
OSAMU SHIRASAKI
Other 510(k) Applications for this Contact
Regulation Number
870.2770
More FDA Info for this Regulation Number
Classification Product Code
MNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/29/2001
Decision Date
11/07/2001
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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