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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 K991918
Device Name NUTRISAFE EXTENSION TUBE
Applicant
Vygon Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
Vygon Corp.
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number876.5980
Classification Product Code
KNT  
Date Received06/07/1999
Decision Date 10/29/1999
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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