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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
Predetermined Change
Control Plan Authorized		 No
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