Cleared Traditional

TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024)

K861618 · Travenol Laboratories, S.A. · Gastroenterology & Urology
Jul 1986
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K861618 is an FDA 510(k) clearance for the TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024), a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on July 15, 1986, 77 days after receiving the submission on April 29, 1986. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K861618 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 1986
Decision Date July 15, 1986
Days to Decision 77 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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