FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K022112
Device Name FORTUNE ALL SILICONE STOMACH (GASTRIC) TUBES, MODEL 2020
Original Applicant
FORTUNE MEDICAL INSTRUMENT CORP.
12-9, lin 5, mao-chang village
san-chih hsiang
taipei hsien, 

TW

252

Original Contact jessica chan
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 06/28/2002
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