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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 K960677
Device Name KANGAROO JEJUNAL FEEDING SYSTEM
Applicant
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Applicant Contact CHERYL WINTERS-HEARD, RAC
Correspondent
Sherwood Medical Co.
1915 Olive St.
St. Louis,  MO  63103
Correspondent Contact CHERYL WINTERS-HEARD, RAC
Regulation Number876.5980
Classification Product Code
KNT  
Date Received02/16/1996
Decision Date 05/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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