Cleared Traditional

MICROFLOW IRRIGATION SYSTEM

K950078 · Jedmed Instrument Co. · Ear, Nose, Throat
Jun 1995
Decision
162d
Days
Class 1
Risk

About This 510(k) Submission

K950078 is an FDA 510(k) clearance for the MICROFLOW IRRIGATION SYSTEM, a Irrigator, Powered Nasal (Class I — General Controls, product code KMA), submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on June 21, 1995, 162 days after receiving the submission on January 10, 1995. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5550.

Submission Details

510(k) Number K950078 FDA.gov
FDA Decision Cleared SESE
Date Received January 10, 1995
Decision Date June 21, 1995
Days to Decision 162 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Statement

Device Classification

Product Code KMA — Irrigator, Powered Nasal
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.5550