Cleared Traditional

K955294 - SOF - ABRASION BUR
(FDA 510(k) Clearance)

K955294 · Trebay Medical Corp. · Ear, Nose, Throat device

Dec 1995

Decision

35d

Days

Class 1

Risk

K955294 is an FDA 510(k) clearance for the SOF - ABRASION BUR. This device is classified as a Bur, Ear, Nose And Throat (Class I - General Controls, product code EQJ).

Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on December 22, 1995, 35 days after receiving the submission on November 17, 1995.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.

Submission Details

510(k) Number	K955294 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 17, 1995
Decision Date	December 22, 1995
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF