Cleared Traditional

SPLINT WOOD

K832144 · Vermont Wood Industries, Inc. · Physical Medicine
Aug 1983
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K832144 is an FDA 510(k) clearance for the SPLINT WOOD, a Splint, Hand, And Components (Class I — General Controls, product code ILH), submitted by Vermont Wood Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 1, 1983, 32 days after receiving the submission on June 30, 1983. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3475.

Submission Details

510(k) Number K832144 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1983
Decision Date August 01, 1983
Days to Decision 32 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