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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 K925854
Device Name VYGON - ENTERAL FEEDING TUBE - POLYURETHANE
Applicant
Vygon Corp.
304 Verona Ave.
Elizabeth,  NJ  07208
Applicant Contact HARRY A SCHLAKMAN
Correspondent
Vygon Corp.
304 Verona Ave.
Elizabeth,  NJ  07208
Correspondent Contact HARRY A SCHLAKMAN
Regulation Number876.5980
Classification Product Code
KNT  
Date Received11/17/1992
Decision Date 05/02/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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