Cleared Traditional

ENT MALLETS

K822204 · Kelleher Corp. · General & Plastic Surgery
Sep 1982
Decision
56d
Days
Class 1
Risk

About This 510(k) Submission

K822204 is an FDA 510(k) clearance for the ENT MALLETS, a Mallet, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFJ), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1982, 56 days after receiving the submission on July 23, 1982. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K822204 FDA.gov
FDA Decision Cleared SESE
Date Received July 23, 1982
Decision Date September 17, 1982
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GFJ — Mallet, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800