Cleared Traditional

K970965 - MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III)
(FDA 510(k) Clearance)

K970965 · Midas Rex Pneumatic Tools, Inc. · Ear, Nose, Throat
Apr 1997
Decision
23d
Days
Class 2
Risk

K970965 is an FDA 510(k) clearance for the MIDAS REX III MOTOR AND ATTACHMENTS (MIDAS III), a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on April 9, 1997, 23 days after receiving the submission on March 17, 1997. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number K970965 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1997
Decision Date April 09, 1997
Days to Decision 23 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.4250

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