Cleared Traditional

FINGER FLEXION SPLINT

K823644 · Fred Sammons, Inc. · Physical Medicine
Jan 1983
Decision
46d
Days
Class 1
Risk

About This 510(k) Submission

K823644 is an FDA 510(k) clearance for the FINGER FLEXION SPLINT, 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 January 21, 1983, 46 days after receiving the submission on December 6, 1982. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K823644 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 1982
Decision Date January 21, 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