Cleared Traditional

MAGNETIC RETENTION UNIT

K811237 · Universiti Malaya · Dental
Jun 1981
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K811237 is an FDA 510(k) clearance for the MAGNETIC RETENTION UNIT, a Sterilizer, Boiling Water (Class I — General Controls, product code ECG), submitted by Universiti Malaya (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981, 43 days after receiving the submission on May 4, 1981. This device falls under the Dental review panel. Regulated under 21 CFR 872.6710.

Submission Details

510(k) Number K811237 FDA.gov
FDA Decision Cleared SESE
Date Received May 04, 1981
Decision Date June 16, 1981
Days to Decision 43 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