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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 K051675
Device Name BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER
Applicant
Biodynamics Corp.
4554 9th Ave. NE, #100
Seattle,  WA  98105
Applicant Contact EDWARD M RIFKIN
Correspondent
Biodynamics Corp.
4554 9th Ave. NE, #100
Seattle,  WA  98105
Correspondent Contact EDWARD M RIFKIN
Regulation Number870.2770
Classification Product Code
MNW  
Date Received06/23/2005
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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