Cleared Traditional

SATO FAMILY FIRST AID KIT

K831706 · Food and Drug Service, Inc. · Physical Medicine
Jun 1983
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K831706 is an FDA 510(k) clearance for the SATO FAMILY FIRST AID KIT, a Sling, Arm (Class I — General Controls, product code ILI), submitted by Food and Drug Service, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1983, 29 days after receiving the submission on May 26, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3640.

Submission Details

510(k) Number K831706 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 1983
Decision Date June 24, 1983
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILI — Sling, Arm
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3640