Cleared Traditional

LAKE MALE EXTERNAL CATHETERIZATION KIT

K902508 · Lake Medical Products, Inc. · Gastroenterology & Urology
Aug 1990
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K902508 is an FDA 510(k) clearance for the LAKE MALE EXTERNAL CATHETERIZATION KIT, a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM), submitted by Lake Medical Products, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 23, 1990, 79 days after receiving the submission on June 5, 1990. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K902508 FDA.gov
FDA Decision Cleared SESD
Date Received June 05, 1990
Decision Date August 23, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

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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