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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 K844789
Device Name KANGAROO ACCESS II ENTERAL FEEDING CONTAINER
Applicant
CHESEBROUGH-POND'S U.S.A. CO.
TRUMBULL INDUSTRIAL PARK
TRUMBULL,  CT  06611
Applicant Contact MICHAEL HUGHES
Correspondent
CHESEBROUGH-POND'S U.S.A. CO.
TRUMBULL INDUSTRIAL PARK
TRUMBULL,  CT  06611
Correspondent Contact MICHAEL HUGHES
Regulation Number876.5980
Classification Product Code
KNT  
Date Received12/10/1984
Decision Date 01/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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