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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 K030203
Device Name LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
Applicant
LONG WELL ELECTRONICS CORP.
3892 SOUTH AMERICA WEST TRAIL
FLAGSTAFF,  AZ  86001
Applicant Contact JENNIFER REICH
Correspondent
LONG WELL ELECTRONICS CORP.
3892 SOUTH AMERICA WEST TRAIL
FLAGSTAFF,  AZ  86001
Correspondent Contact JENNIFER REICH
Regulation Number870.2770
Classification Product Code
MNW  
Date Received01/21/2003
Decision Date 04/21/2003
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
Predetermined Change
Control Plan Authorized		 No
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