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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubes, gastrointestinal (and accessories)
510(k) Number K162340
Device Name Stomach Tube
Applicant
WELL LEAD MEDICAL CO., LTD
C-4# JINHU INDUSTRIAL ESTATE
HUALONG, PANYU
GUANGZHOU,  CN 511434
Applicant Contact HUANG KAI GEN
Correspondent
WELL LEAD MEDICAL CO., LTD
C-4# JINHU INDUSTRIAL ESTATE
HUALONG, PANYU
GUANGZHOU,  CN 511434
Correspondent Contact HUANG KAI GEN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received08/22/2016
Decision Date 10/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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