Cleared Traditional

EAR PROBES

K822568 · Kelleher Corp. · Dental
Sep 1982
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K822568 is an FDA 510(k) clearance for the EAR PROBES, a Point, Silver, Endodontic (Class I — General Controls, product code EKL), submitted by Kelleher Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982, 21 days after receiving the submission on August 24, 1982. This device falls under the Dental review panel. Regulated under 21 CFR 872.3840.

Submission Details

510(k) Number K822568 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 1982
Decision Date September 14, 1982
Days to Decision 21 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EKL — Point, Silver, Endodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3840