Cleared Traditional

DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE

K900324 · Biosearch Medical Products, Inc. · Gastroenterology & Urology
Aug 1990
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K900324 is an FDA 510(k) clearance for the DOBBHOFF WIRE GUIDED JEJUNAL FEEDING TUBE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Biosearch Medical Products, Inc. (Somerville, US). The FDA issued a Cleared decision on August 2, 1990, 191 days after receiving the submission on January 23, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K900324 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 1990
Decision Date August 02, 1990
Days to Decision 191 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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