DECLARATION OF CONFORMITY
THE ARGEN CORPORATION
located at
5855 Oberlin Drive San Diego,CA92121-4718
declares, under our sole responsibility,
The Following Dental Alloy Product:
ARGENCO Y+
Complies with the legislation of
ISO 13485 - Medical Devices - Particular requirements for the application of ISO 9001;
Following the Provisions of
93/42/EEC; Annex II - Council of European Communities
Directive Concerning
Medical Devices.
|
Manufacturer |
EC Representative
|
|
THE ARGEN CORPORATION |
Medical Device Safety Service Gmbh,
|
|
5855 Oberlin Drive |
Schiffgraben 41, D-30175
|
|
San Diego, CA 92121-4718 |
Hannover,Germany
|
Issued By:
Craig Jolicoeur
Quality and Regulatory Assurance Manager
** This document is generated electronically and does not require a signature **
Print date: 11/21/2024