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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
Original Applicant
no. 1 fanghua street
hi-tech district
chengdu,  CN 610041
Original Contact leo wang
Regulation Number870.2770
Classification Product Code
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