Cleared Traditional

ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG

K944378 · Regulatory & Marketing Services, Inc. · Gastroenterology & Urology
Feb 1995
Decision
161d
Days
Class 1
Risk

About This 510(k) Submission

K944378 is an FDA 510(k) clearance for the ORION'S URETHRAL CATHETERIZATION KIT WITH CATHETER AND BAG, a Probe And Director, Gastro-urology (Class I — General Controls, product code FGM), submitted by Regulatory & Marketing Services, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on February 15, 1995, 161 days after receiving the submission on September 7, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K944378 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1994
Decision Date February 15, 1995
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code FGM — Probe And Director, Gastro-urology
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.4730

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