September 3
Noveko achieved a new milestone in the process of approval by the FDA of its antimicrobial face masks
Noveko International Inc. (the \"Corporation\") is pleased to announce that its subsidiary, Noveko Inc. (\"Noveko\"), has completed a new step in the process for approval by the Food and Drugs Administration (the \"FDA\") of its 3xEz antimicrobial surgical mask. The FDA has in fact granted to Noveko a 510(k) submission number, which means, that, in principle, Noveko\'s application is now completed. However, the FDA, reserved its right to require additional information prior to approve, or not, the use of the Noveko\'s 3xEz antimicrobial surgical mask in the USA.
We remind that further to the July 19, 2007 guidance issued by the Center for Devices and Radiology Health, FDA, Noveko had to develop and then submit in September 2007 to the FDA a set of safety and performance protocols to meet the new high standards for antimicrobial surgical face masks of the US authorities; this has slowed down the approval process. On December 4, 2007, we announced that the FDA approved our protocols. Thereafter, we have fulfilled all the other formalities to complete our application, which result in the grant of this submission number.
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Published: 03 September 2008
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Written by Editor
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Read more: Noveko International Inc ( EKO )