Cleared Traditional

ADMINISTRATION SET

K810131 · G.D. Searle and Co. · Gastroenterology & Urology
Feb 1981
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K810131 is an FDA 510(k) clearance for the ADMINISTRATION SET, a Tube, Feeding (Class II — Special Controls, product code FPD), submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on February 26, 1981, 38 days after receiving the submission on January 19, 1981. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K810131 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 1981
Decision Date February 26, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code FPD — Tube, Feeding
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5980

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