Cleared Traditional

TINY FLEX-GLASS, SET OF 4

K821646 · Fred Sammons, Inc. · Physical Medicine
Jun 1982
Decision
8d
Days
Class 1
Risk

About This 510(k) Submission

K821646 is an FDA 510(k) clearance for the TINY FLEX-GLASS, SET OF 4, a Utensil, Homemaking (Class I — General Controls, product code IKW), 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 K821646 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 IKW — Utensil, Homemaking
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5050