Cleared Traditional

ADJUSTABLE WRENCHES

K874359 · Med-Tool, Inc. · Orthopedic
Nov 1987
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K874359 is an FDA 510(k) clearance for the ADJUSTABLE WRENCHES, a Wrench (Class I — General Controls, product code HXC), submitted by Med-Tool, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 23, 1987, 31 days after receiving the submission on October 23, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K874359 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1987
Decision Date November 23, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code HXC — Wrench
Device Class Class I — General Controls
CFR Regulation 21 CFR 888.4540