Cleared Traditional

K791073 - WRENCH
(FDA 510(k) Clearance)

K791073 · Truth, Inc. · Orthopedic
Jun 1979
Decision
8d
Days
Class 1
Risk

K791073 is an FDA 510(k) clearance for the WRENCH, a Wrench (Class I — General Controls, product code HXC), submitted by Truth, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 20, 1979, 8 days after receiving the submission on June 12, 1979. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number K791073 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1979
Decision Date June 20, 1979
Days to Decision 8 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