Cleared Traditional

ARM SLINGS

K831549 · Fred Sammons, Inc. · Physical Medicine
Jun 1983
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K831549 is an FDA 510(k) clearance for the ARM SLINGS, a Sling, Arm (Class I — General Controls, product code ILI), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1983, 49 days after receiving the submission on May 12, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3640.

Submission Details

510(k) Number K831549 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 30, 1983
Days to Decision 49 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