Cleared Traditional

K823156 - COLLAPSABLE LAVATORY HEIGHTENER
(FDA 510(k) Clearance)

K823156 · Orthion Corp. · Physical Medicine
Nov 1982
Decision
16d
Days
Class 1
Risk

K823156 is an FDA 510(k) clearance for the COLLAPSABLE LAVATORY HEIGHTENER. This device is classified as a Adaptor, Hygiene (Class I — General Controls, product code ILS).

Submitted by Orthion Corp. (Mchenry, US). The FDA issued a Cleared decision on November 5, 1982, 16 days after receiving the submission on October 20, 1982.

This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K823156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1982
Decision Date November 05, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code ILS — Adaptor, Hygiene
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5050