Cleared Traditional

EATING UTENSILS

K821643 · Fred Sammons, Inc. · Physical Medicine
Jun 1982
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K821643 is an FDA 510(k) clearance for the EATING UTENSILS, a Utensil, Eating (Class I — General Controls, product code ILC), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 11, 1982, 8 days after receiving the submission on June 3, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K821643 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 1982
Decision Date June 11, 1982
Days to Decision 8 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary

Device Classification

Product Code ILC — Utensil, Eating
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5050