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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 K973409
Device Name KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
Applicant
Davis & Geck, Inc.
444 Mc Donnell Blvd.
Hazlewood,  MO  63042
Applicant Contact VANADA JOHNSON
Correspondent
Davis & Geck, Inc.
444 Mc Donnell Blvd.
Hazlewood,  MO  63042
Correspondent Contact VANADA JOHNSON
Regulation Number876.5980
Classification Product Code
KNT  
Date Received09/09/1997
Decision Date 02/27/1998
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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