Kangaroo Access II Enteral Feeding Container

FDA 510(k) K844789 · Chesebrough-Pond'S U.S.A. Co.

Substantially Equivalent

510(k) numberK844789

Submission

Device name
Kangaroo Access II Enteral Feeding Container
Applicant
Chesebrough-Pond'S U.S.A. Co.
Trumbull, CT, US
Received
December 10, 1984
Decision date
January 2, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KNT – Tubes, Gastrointestinal (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

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More from Degania Silicone , Ltd.

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K862803Chesebrough Pond's Hydrocolloid DressingFRO · Traditional 11/14/1986SN
K851383Blisterfilm Transparent DressingNAD · Traditional 07/05/1985SN
K851382Chesebrough-Pond's Sequential Wound DressingNAD · Traditional 07/05/1985SN
K851539Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap CloKNT · Traditional 06/12/1985SE
K843567Kangaroo Nasogastric Feeding TubeKNT · Traditional 02/14/1985SE
K845010Chesebrough-Pond's Uri-Drain Male Urinary PouchEYQ · Traditional 01/15/1985SE
K844186Continent Stoma System & AccessoriesKBG · Traditional 01/15/1985SE
K843128Female Urinary Incontinence SysKNX · Traditional 01/02/1985SE
K843140Isolate Adhesive Bandage for Dry WoundNAD · Traditional 11/08/1984SE

Questions and answers

When was Kangaroo Access II Enteral Feeding Container cleared by the FDA?

Kangaroo Access II Enteral Feeding Container (K844789) received a 510(k) decision of Substantially Equivalent on January 2, 1985, 23 days after the submission was received.

What is the product code of K844789?

The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.