Cleared Traditional

K952227 - C-FLEX ENDOLYMPHATIC SHUNT
(FDA 510(k) Clearance)

K952227 · Trebay Medical Corp. · Ear, Nose, Throat device

Jun 1995

Decision

35d

Days

Class 2

Risk

K952227 is an FDA 510(k) clearance for the C-FLEX ENDOLYMPHATIC SHUNT. This device is classified as a Tube, Shunt, Endolymphatic (Class II - Special Controls, product code ESZ).

Submitted by Trebay Medical Corp. (Clearwater, US). The FDA issued a Cleared decision on June 16, 1995, 35 days after receiving the submission on May 12, 1995.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.3820.

Submission Details

510(k) Number	K952227 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 12, 1995
Decision Date	June 16, 1995
Days to Decision	35 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF