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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 K860285
Device Name XRO GASTRO-DUODENAL, DUAL FLOW TUBE, SALEM TYPE
Applicant
Vygon Corp.
1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact TONY J RIVERS
Correspondent
Vygon Corp.
1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact TONY J RIVERS
Regulation Number876.5980
Classification Product Code
KNT  
Date Received01/28/1986
Decision Date 02/11/1986
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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