Cleared Traditional

MEDICAL TOILET SEAT

K852049 · Pedro Aleman · Physical Medicine
Jun 1985
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K852049 is an FDA 510(k) clearance for the MEDICAL TOILET SEAT, a Adaptor, Hygiene (Class I — General Controls, product code ILS), submitted by Pedro Aleman (D.F. Mexico, MX). The FDA issued a Cleared decision on June 24, 1985, 47 days after receiving the submission on May 8, 1985. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K852049 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 1985
Decision Date June 24, 1985
Days to Decision 47 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