Cleared Traditional

K861954 - HEXAGONAL WRENCHES
(FDA 510(k) Clearance)

Jun 1986
Decision
17d
Days
Risk

K861954 is an FDA 510(k) clearance for the HEXAGONAL WRENCHES..

Submitted by Med-Tool, Inc. (St. Louis, US). The FDA issued a Cleared decision on June 6, 1986, 17 days after receiving the submission on May 20, 1986.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K861954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1986
Decision Date June 06, 1986
Days to Decision 17 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class