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FDA 510(k) Application Details - K110689
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K110689
Device Name
Analyzer, Body Composition
Applicant
BIOSPACE CORPORATION LIMITED
8870 RAVELLO CT
NAPLES, FL 34114 US
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Contact
DANIEL KAMM
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
03/15/2011
Decision Date
08/19/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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