Cleared Traditional

K875224 - HUDSON CRANINAL BURRS (FDA 510(k) Clearance)

K875224 · Tri-Med, Inc. · Neurology device

Jan 1988

Decision

37d

Days

Class 2

Risk

K875224 is an FDA 510(k) clearance for the HUDSON CRANINAL BURRS. This device is classified as a Drills, Burrs, Trephines & Accessories (simple, Powered) (Class II - Special Controls, product code HBE).

Submitted by Tri-Med, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 28, 1988, 37 days after receiving the submission on December 22, 1987.

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

Submission Details

510(k) Number	K875224 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 22, 1987
Decision Date	January 28, 1988
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	—