Cleared Traditional

POWDER BLOWERS

K822351 · Kelleher Corp. · Ear, Nose, Throat
Sep 1982
Decision
39d
Days
Class 1
Risk

About This 510(k) Submission

K822351 is an FDA 510(k) clearance for the POWDER BLOWERS, a Irrigator, Powered Nasal (Class I — General Controls, product code KMA), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 39 days after receiving the submission on August 6, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.5550.

Submission Details

510(k) Number K822351 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1982
Decision Date September 14, 1982
Days to Decision 39 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

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