Cleared Special

PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907

K050777 · Conmedcorp · Gastroenterology & Urology
Apr 2005
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K050777 is an FDA 510(k) clearance for the PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Conmedcorp (Billerica, US). The FDA issued a Cleared decision on April 22, 2005, 25 days after receiving the submission on March 28, 2005. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.

Submission Details

510(k) Number K050777 FDA.gov
FDA Decision Cleared SESE
Date Received March 28, 2005
Decision Date April 22, 2005
Days to Decision 25 days
Submission Type Special
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FGE — Stents, Drains And Dilators For The Biliary Ducts
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5010

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