Cleared Traditional

BK-1129 BOTTLE STRAW

K813630 · Fred Sammons, Inc. · Physical Medicine
Jan 1982
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K813630 is an FDA 510(k) clearance for the BK-1129 BOTTLE STRAW, a Utensil, Eating (Class I — General Controls, product code ILC), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 19, 1982, 21 days after receiving the submission on December 29, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.

Submission Details

510(k) Number K813630 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 1981
Decision Date January 19, 1982
Days to Decision 21 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