Cleared Traditional

K811428 - NORTHWESTERN VOICE RESTORATION KIT (FDA 510(k) Clearance)

K811428 · Universal Prosthetics, Inc. · Ear, Nose, Throat device

Jun 1981

Decision

25d

Days

Class 1

Risk

K811428 is an FDA 510(k) clearance for the NORTHWESTERN VOICE RESTORATION KIT. This device is classified as a Tube, Laryngectomy (Class I - General Controls, product code KAC).

Submitted by Universal Prosthetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981, 25 days after receiving the submission on May 22, 1981.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K811428 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 22, 1981
Decision Date	June 16, 1981
Days to Decision	25 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—