Cleared Traditional

FRENZEL EYEGLASSES & RELATED ITEMS

K822179 · Kelleher Corp. · Ear, Nose, Throat
Sep 1982
Decision
60d
Days
Class 1
Risk

About This 510(k) Submission

K822179 is an FDA 510(k) clearance for the FRENZEL EYEGLASSES & RELATED ITEMS, a Stimulator, Caloric-air (Class I — General Controls, product code KHH), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1982, 60 days after receiving the submission on July 23, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.1800.

Submission Details

510(k) Number K822179 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1982
Decision Date September 21, 1982
Days to Decision 60 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code KHH — Stimulator, Caloric-air
Device Class Class I — General Controls
CFR Regulation 21 CFR 874.1800