Cleared Traditional

ALUMINUM SCOOP DISK

K812346 · Fred Sammons, Inc. · Physical Medicine
Sep 1981
Decision
24d
Days
Class 1
Risk

About This 510(k) Submission

K812346 is an FDA 510(k) clearance for the ALUMINUM SCOOP DISK, a Utensil, Eating (Class I — General Controls, product code ILC), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1981, 24 days after receiving the submission on August 18, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K812346 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 1981
Decision Date September 11, 1981
Days to Decision 24 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