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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 K112932
Device Name TRANSTEK
Applicant
Zhongshan Transtek Electronics Co., Ltd.
#1 Fanghua St., Hi-Tech District
Chengdu, Sichuan,  CN 610041
Applicant Contact LEO WANG
Correspondent
Zhongshan Transtek Electronics Co., Ltd.
#1 Fanghua St., Hi-Tech District
Chengdu, Sichuan,  CN 610041
Correspondent Contact LEO WANG
Regulation Number870.2770
Classification Product Code
MNW  
Date Received10/03/2011
Decision Date 11/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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