Cleared Traditional

INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS

K961593 · Segi Hearing Aid Co. · Ear, Nose, Throat

Nov 1996

Decision

197d

Days

Class 1

Risk

About This 510(k) Submission

K961593 is an FDA 510(k) clearance for the INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS, a Face Plate Hearing Aid (Class I — General Controls, product code LRB), submitted by Segi Hearing Aid Co. (New York, US). The FDA issued a Cleared decision on November 7, 1996, 197 days after receiving the submission on April 24, 1996. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3300.

Submission Details

510(k) Number	K961593 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 1996
Decision Date	November 07, 1996
Days to Decision	197 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF