Cleared Traditional

K843567 - KANGAROO NASOGASTRIC FEEDING TUBE
(FDA 510(k) Clearance)

Feb 1985
Decision
157d
Days
Class 2
Risk

K843567 is an FDA 510(k) clearance for the KANGAROO NASOGASTRIC FEEDING TUBE. This device is classified as a Tubes, Gastrointestinal (and Accessories) (Class II - Special Controls, product code KNT).

Submitted by Chesebrough-Pond'S U.S.A. Co. (Trumbull, US). The FDA issued a Cleared decision on February 14, 1985, 157 days after receiving the submission on September 10, 1984.

This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K843567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date February 14, 1985
Days to Decision 157 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary

Device Classification

Product Code KNT — Tubes, Gastrointestinal (and Accessories)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 876.5980

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