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FDA 510(k) Application Details - K081587
Device Classification Name
Analyzer, Body Composition
More FDA Info for this Device
510(K) Number
K081587
Device Name
Analyzer, Body Composition
Applicant
KRELL PRECISION (YANG ZHOU) CO., LTD.
340 SHADY GROVE RD.
FLINTVILLE, TN 37335-5031 US
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Contact
CHARLIE MACK
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
06/05/2008
Decision Date
10/24/2008
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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