Cleared Traditional

CONPHAR SILICONE FEEDING TUBE

K821825 · Conphar, Inc. · Gastroenterology & Urology
Aug 1982
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K821825 is an FDA 510(k) clearance for the CONPHAR SILICONE FEEDING TUBE, a Tubes, Gastrointestinal (and Accessories) (Class II — Special Controls, product code KNT), submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1982, 49 days after receiving the submission on June 22, 1982. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5980.

Submission Details

510(k) Number K821825 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1982
Decision Date August 10, 1982
Days to Decision 49 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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