Cleared Traditional

K950930 - TRACHE-TITE
(FDA 510(k) Clearance)

K950930 · The Varner Group, Inc. · Anesthesiology

Mar 1995

Decision

21d

Days

Class 1

Risk

K950930 is an FDA 510(k) clearance for the TRACHE-TITE. This device is classified as a Device, Fixation, Tracheal Tube (Class I — General Controls, product code CBH).

Submitted by The Varner Group, Inc. (Washington, US). The FDA issued a Cleared decision on March 22, 1995, 21 days after receiving the submission on March 1, 1995.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5770.

Submission Details

510(k) Number	K950930 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 1995
Decision Date	March 22, 1995
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement