Cleared Traditional

K862852 - MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR
(FDA 510(k) Clearance)

K862852 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery

Aug 1986

Decision

13d

Days

Class 1

Risk

K862852 is an FDA 510(k) clearance for the MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTR, a Bur, Surgical, General & Plastic Surgery (Class I — General Controls, product code GFF), submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on August 11, 1986, 13 days after receiving the submission on July 29, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4820.

Submission Details

510(k) Number	K862852 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 1986
Decision Date	August 11, 1986
Days to Decision	13 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—