US Regulatory Agency Provides Favorable Review and Recommends Path for Approval - TSO3 Inc. (TOS) to Pursue De Novo Process Classification
4/17/2013 11:38:04 AM
QUEBEC CITY, QC, April 17, 2013 /CNW Telbec/ - TSO3 Inc. ("TSO3") an innovator in low-temperature sterilization technology for medical devices in healthcare settings, today announced that upon review of the current 510(k) submission for the STERIZONE® 125L+ Sterilizer, the US Regulatory Agency has recognized the quality of the science provided and the performance of the device, as well as the uniqueness of the TSO3 proprietary technology. The Agency is of the opinion that there is no predicate to this device available on the market and that it is eligible for the de novo classification as a new standard. After evaluation of this option, the Company has decided to pursue the de novo approval pathway. The Company believes that this will not affect the overall timeline for approval to market.
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