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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 K131394
Device Name TRANSTEK GLASS BODY FAT ANALYZER
Applicant
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
NO.1 FANGHUA STREET, HI-TECH DISTRICT
CHENGDU, SICHUAN,  CN 610041
Applicant Contact LEO WANG
Correspondent
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
NO.1 FANGHUA STREET, HI-TECH DISTRICT
CHENGDU, SICHUAN,  CN 610041
Correspondent Contact LEO WANG
Regulation Number870.2770
Classification Product Code
MNW  
Date Received05/15/2013
Decision Date 09/18/2013
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
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