Cleared Traditional

NHMC URETHRAL CATHETERIZATION TRAY

K962254 · National Healthcare Mfg. Corp. · Gastroenterology & Urology
Jul 1996
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K962254 is an FDA 510(k) clearance for the NHMC URETHRAL CATHETERIZATION TRAY, a Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit) (Class II — Special Controls, product code FCM), submitted by National Healthcare Mfg. Corp. (Winnipeg, Mb, CA). The FDA issued a Cleared decision on July 29, 1996, 47 days after receiving the submission on June 12, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K962254 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1996
Decision Date July 29, 1996
Days to Decision 47 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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