Cleared Traditional

MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50

K896280 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery
Nov 1989
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K896280 is an FDA 510(k) clearance for the MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50, a Blade, Saw, General & Plastic Surgery, Surgical (Class I — General Controls, product code GFA), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on November 22, 1989, 22 days after receiving the submission on October 31, 1989. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K896280 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1989
Decision Date November 22, 1989
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GFA — Blade, Saw, General & Plastic Surgery, Surgical
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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