Cleared Traditional

SPLINTS

K831548 · Fred Sammons, Inc. · Physical Medicine
Jun 1983
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K831548 is an FDA 510(k) clearance for the SPLINTS, a Splint, Hand, And Components (Class I — General Controls, product code ILH), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1983, 46 days after receiving the submission on May 12, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K831548 FDA.gov
FDA Decision Cleared SESE
Date Received May 12, 1983
Decision Date June 27, 1983
Days to Decision 46 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary —

Device Classification

Product Code ILH — Splint, Hand, And Components
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.3475