Cleared Traditional

TOILET SEAT RAISED

K830425 · Maddak, Inc. · Physical Medicine
May 1983
Decision
89d
Days
Class 1
Risk

About This 510(k) Submission

K830425 is an FDA 510(k) clearance for the TOILET SEAT RAISED, a Adaptor, Hygiene (Class I — General Controls, product code ILS), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983, 89 days after receiving the submission on February 9, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K830425 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 1983
Decision Date May 09, 1983
Days to Decision 89 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