Cleared Traditional

K874358 - COMBINATION WRENCHES
(FDA 510(k) Clearance)

K874358 · Med-Tool, Inc. · Orthopedic device

Nov 1987

Decision

31d

Days

Class 1

Risk

K874358 is an FDA 510(k) clearance for the COMBINATION WRENCHES. This device is classified as 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 FDA review panel. Regulated under 21 CFR 888.4540.

Submission Details

510(k) Number	K874358 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 23, 1987
Decision Date	November 23, 1987
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	—