Cleared Traditional

K854123 - MIDAS REX OPERATING ROOM VISE
(FDA 510(k) Clearance)

Nov 1985
Decision
35d
Days
Risk

K854123 is an FDA 510(k) clearance for the MIDAS REX OPERATING ROOM VISE..

Submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on November 13, 1985, 35 days after receiving the submission on October 9, 1985.

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

Submission Details

510(k) Number K854123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1985
Decision Date November 13, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary

Device Classification

Product Code
Device Class