Cleared Traditional

LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR)

K901835 · Lake Medical Products, Inc. · Gastroenterology & Urology
Sep 1990
Decision
139d
Days
Class 2
Risk

About This 510(k) Submission

K901835 is an FDA 510(k) clearance for the LAKE N/G FEEDING TUBE (WITH Y PORT CONNECTOR), a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 5, 1990, 139 days after receiving the submission on April 19, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K901835 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1990
Decision Date September 05, 1990
Days to Decision 139 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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