Cleared Traditional

K903664 - MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL (FDA 510(k) Clearance)

K903664 · Micro-Aire Surgical Instruments, Inc. · Neurology device

Sep 1990

Decision

30d

Days

Class 2

Risk

K903664 is an FDA 510(k) clearance for the MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on September 13, 1990, 30 days after receiving the submission on August 14, 1990.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4310.

Submission Details

510(k) Number	K903664 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 14, 1990
Decision Date	September 13, 1990
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—