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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 K022112
Device Name FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
Applicant
FORTUNE MEDICAL INSTRUMENT CORP.
12-9, LIN 5, MAO-CHANG VILLAGE
SAN-CHIH HSIANG
TAIPEI HSIEN,  TW 252
Applicant Contact JESSICA CHAN
Correspondent
FORTUNE MEDICAL INSTRUMENT CORP.
12-9, LIN 5, MAO-CHANG VILLAGE
SAN-CHIH HSIANG
TAIPEI HSIEN,  TW 252
Correspondent Contact JESSICA CHAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/28/2002
Decision Date 04/03/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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