Cleared Traditional

K823633 - TURNERS FOR KNOBS
(FDA 510(k) Clearance)

Dec 1982
Decision
22d
Days
Class 1
Risk

K823633 is an FDA 510(k) clearance for the TURNERS FOR KNOBS. This device is classified as a Utensil, Homemaking (Class I - General Controls, product code IKW).

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 22 days after receiving the submission on December 6, 1982.

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

Submission Details

510(k) Number K823633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date December 28, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code IKW — Utensil, Homemaking
Device Class Class I - General Controls
CFR Regulation 21 CFR 890.5050