Cleared Traditional

NHMC FOLEY CATHETERIZATION TRAY

K960566 · National Healthcare Mfg. Corp. · Gastroenterology & Urology
Feb 1996
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K960566 is an FDA 510(k) clearance for the NHMC FOLEY 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 February 29, 1996, 20 days after receiving the submission on February 9, 1996. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K960566 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1996
Decision Date February 29, 1996
Days to Decision 20 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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