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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, body composition
510(k) Number K091369
Device Name ELECTROFLUIDGRAPH
Applicant
AKERN USA, LLC
5401 S. COTTONWOOD COURT
GREENWOOD VILLAGE,  CO  80121
Applicant Contact KEVIN WELLS
Correspondent
AKERN USA, LLC
5401 S. COTTONWOOD COURT
GREENWOOD VILLAGE,  CO  80121
Correspondent Contact KEVIN WELLS
Regulation Number870.2770
Classification Product Code
MNW  
Date Received05/08/2009
Decision Date 10/14/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Clinical Trials NCT00956917
Reviewed by Third Party No
Combination Product No
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