COLD LIGHT SOURCE LOS 150— 510(k) K951829

Name: FDA 510(k) clearance K951829
Creator: U.S. Food and Drug Administration
Published: 1995-07-10

Substantially Equivalent

Laser-Optik-Systeme GmbH & Co. KG

FDA 510(k) clearance K951829 for COLD LIGHT SOURCE LOS 150, Substantially Equivalent on 1995-07-10. Applicant: Laser-Optik-Systeme GmbH & Co. KG. Device class: 1.

Clearance details

Applicant: Laser-Optik-Systeme GmbH & Co. KG
Product code: Code EQH
Device class: Class 1
Regulation: 21 CFR 874.4350
Advisory panel: Ear, Nose, Throat
Date received: 1995-04-20
Decision date: 1995-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mainz, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.