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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 K020738
Device Name AVITA BF1 (VITALIO) BODY FAT ANALYZER
Applicant
AVITA CORPORATION
3892 SOUTH AMERICA WEST TRAIL,
FLAGGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
AVITA CORPORATION
3892 SOUTH AMERICA WEST TRAIL,
FLAGGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.2770
Classification Product Code
MNW  
Date Received03/06/2002
Decision Date 05/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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