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Announcement on Obtaining Sales Approval for Radiation-Induced Enteritis Healing Material Our company, through its US subsidiary 3-D Matrix, Inc., has applied to the U.S. Food and Drug Administration (hereafter "FDA") for the market approval of a wound healing material intended for Radiation Proctitis (radiation-induced enteritis) as a medical device (Class II) via a premarket notification 510(k) (hereafter "510(k)"). We are pleased to inform you that FDA has granted approval. In addition, the premarket notification 510(k) for the oral mucositis healing material, which served as a reference product for this application, has already been approved by the FDA in October 2021.
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