Cleared Traditional

URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY

K962073 · Continental Medical Laboratories, Inc. · Gastroenterology & Urology
Jun 1996
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K962073 is an FDA 510(k) clearance for the URETHRAL CATHETERIZATION TRAY/UNIVERSAL URETHRAL CATH TRAY, a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM), submitted by Continental Medical Laboratories, Inc. (Waterford, US). The FDA issued a Cleared decision on June 21, 1996, 24 days after receiving the submission on May 28, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K962073 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1996
Decision Date June 21, 1996
Days to Decision 24 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FCM — Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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