Cleared Traditional

K923656 - LIGHTING SOURCE SYSTEM (FDA 510(k) Clearance)

K923656 · Galenica Enterprises, Inc. · Obstetrics & Gynecology device

Sep 1994

Decision

787d

Days

Class 2

Risk

K923656 is an FDA 510(k) clearance for the LIGHTING SOURCE SYSTEM. This device is classified as a Speculum, Vaginal, Nonmetal, Fiberoptic (Class II - Special Controls, product code HIC).

Submitted by Galenica Enterprises, Inc. (Quebec Canada J7e 4h7, CA). The FDA issued a Cleared decision on September 8, 1994, 787 days after receiving the submission on July 13, 1992.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K923656 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 13, 1992
Decision Date	September 08, 1994
Days to Decision	787 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement