510(k) K844789

KANGAROO ACCESS II ENTERAL FEEDING CONTAINER by Chesebrough-Pond'S U.S.A. Co. — Product Code KNT

K844789 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "KANGAROO ACCESS II ENTERAL FEEDING CONTAINER". The FDA issued a decision of Substantially Equivalent on January 2, 1985. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1985
Date Received
December 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type