Cleared Traditional

K900388 - MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES (FDA 510(k) Clearance)

K900388 · Midas Rex Pneumatic Tools, Inc. · Radiology device

May 1990

Decision

98d

Days

Class 2

Risk

K900388 is an FDA 510(k) clearance for the MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Midas Rex Pneumatic Tools, Inc. (Fort Worth, US). The FDA issued a Cleared decision on May 7, 1990, 98 days after receiving the submission on January 29, 1990.

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

Submission Details

510(k) Number	K900388 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 29, 1990
Decision Date	May 07, 1990
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	—