Cleared Traditional

CITOMAT AUTOCLAVES

K843234 · Lic-Orthion · Dental
Oct 1984
Decision
69d
Days
Class 1
Risk

About This 510(k) Submission

K843234 is an FDA 510(k) clearance for the CITOMAT AUTOCLAVES, a Sterilizer, Boiling Water (Class I — General Controls, product code ECG), submitted by Lic-Orthion (Washington, US). The FDA issued a Cleared decision on October 25, 1984, 69 days after receiving the submission on August 17, 1984. This device falls under the Dental review panel. Regulated under 21 CFR 872.6710.

Submission Details

510(k) Number K843234 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1984
Decision Date October 25, 1984
Days to Decision 69 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ECG — Sterilizer, Boiling Water
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6710