Cleared Traditional

K872491 - 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS
(FDA 510(k) Clearance)

K872491 · Micro-Aire Surgical Instruments, Inc. · General & Plastic Surgery

Jul 1987

Decision

23d

Days

Class 1

Risk

K872491 is an FDA 510(k) clearance for the 1.1 TWIST DRILLS AND 1.2 CORTICAL DRILLS, a Elevator, Surgical, General & Plastic Surgery (Class I — General Controls, product code GEG), submitted by Micro-Aire Surgical Instruments, Inc. (San Fernando, US). The FDA issued a Cleared decision on July 16, 1987, 23 days after receiving the submission on June 23, 1987. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number	K872491 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 1987
Decision Date	July 16, 1987
Days to Decision	23 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—