Cleared Traditional

MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL

K903664 · Micro-Aire Surgical Instruments, Inc. · Neurology
Sep 1990
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K903664 is an FDA 510(k) clearance for the MICRO-AIRE WIRE PASS AND CRANIOTOME DRILL, 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 review panel. Regulated under 21 CFR 882.4310.

Submission Details

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

Device Classification

Product Code HBE — Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4310

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