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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 K083838
Device Name SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES
Applicant
Fook Tin Technologies Limited
4/F., Eastern Centre
1065 King'S Rd.
Quarry Bay,  HK
Applicant Contact JOHN CHAI
Correspondent
Fook Tin Technologies Limited
4/F., Eastern Centre
1065 King'S Rd.
Quarry Bay,  HK
Correspondent Contact JOHN CHAI
Regulation Number870.2770
Classification Product Code
MNW  
Date Received12/23/2008
Decision Date 05/12/2009
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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