Cleared Traditional

MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS

K900033 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery
Feb 1990
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K900033 is an FDA 510(k) clearance for the MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTS, a Motor, Surgical Instrument, Ac-powered (Class I — General Controls, product code GEY), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on February 13, 1990, 42 days after receiving the submission on January 2, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number K900033 FDA.gov
FDA Decision Cleared SESE
Date Received January 02, 1990
Decision Date February 13, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GEY — Motor, Surgical Instrument, Ac-powered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4820

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