Cleared Traditional

GLOSSECTOMY FEEDING SPOONS

K833177 · Maddak, Inc. · Physical Medicine
Oct 1983
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K833177 is an FDA 510(k) clearance for the GLOSSECTOMY FEEDING SPOONS, a Utensil, Eating (Class I — General Controls, product code ILC), submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1983, 42 days after receiving the submission on September 19, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K833177 FDA.gov
FDA Decision Cleared SESE
Date Received September 19, 1983
Decision Date October 31, 1983
Days to Decision 42 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