Cleared Traditional

MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS

K894438 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery
Aug 1989
Decision
35d
Days
Class 1
Risk

About This 510(k) Submission

K894438 is an FDA 510(k) clearance for the MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTS, a Bur, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFF), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on August 21, 1989, 35 days after receiving the submission on July 17, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K894438 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 1989
Decision Date August 21, 1989
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GFF — Bur, Surgical, General & Plastic Surgery
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820