LIGHTING SOURCE SYSTEM— 510(k) K923656

Name: FDA 510(k) clearance K923656
Creator: U.S. Food and Drug Administration
Published: 1994-09-08

Substantially Equivalent

Galenica Enterprises, Inc.

FDA 510(k) clearance K923656 for LIGHTING SOURCE SYSTEM, Substantially Equivalent on 1994-09-08. Applicant: Galenica Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Galenica Enterprises, Inc.
Product code: Code HIC
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1992-07-13
Decision date: 1994-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Quebec Canada J7e 4h7, CA

Download summary PDF View on FDA.gov ↗

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