Cleared Traditional

K954912 - TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)
(FDA 510(k) Clearance)

K954912 · Trebay Medical Corp. · Ear, Nose, Throat device

Dec 1995

Decision

44d

Days

Class 1

Risk

K954912 is an FDA 510(k) clearance for the TREBAY IRRIGATED CUTTER BLADE (MODIFICATION). 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 6, 1995, 44 days after receiving the submission on October 23, 1995.

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

Submission Details

510(k) Number	K954912 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 23, 1995
Decision Date	December 06, 1995
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF