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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 K871003
Device Name ENTROSET-SW
Applicant
White River (Tm)
P.O. Box 1704
Beaverton,  OR  97005
Applicant Contact ELENA GRANT
Correspondent
White River (Tm)
P.O. Box 1704
Beaverton,  OR  97005
Correspondent Contact ELENA GRANT
Regulation Number876.5980
Classification Product Code
KNT  
Date Received03/12/1987
Decision Date 06/04/1987
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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