MAXXON, INC (MXON.Nasdaq BB) Disposable syringe technology Message Board

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Biotech / Medical : MAXXON, INC (MXON.Nasdaq BB) Disposable syringe technology

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To: Bruno who started this subject	12/13/2002 7:13:26 PM
From: bcjt	of 105

Maxxon Inc. Quick Quote: MXON 0.19 (+0.01) Maxxon Announces FDA 510-K- Response 12/13/02 TULSA, Okla, Dec 13, 2002 (BUSINESS WIRE) -- Maxxon, Inc. today announced that the FDA has responded to the Company's 510(k) application for its 12cc safety syringe. The FDA has reclassified this version of the safety syringe as a Class III device instead of a Class I device because the 12cc design is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976. A Class III device requires a Pre-Market Approval (PMA) application to obtain U.S. marketing approval. A PMA application is more extensive and requires more testing than a 510(k) application. The 12cc version of the safety syringe was initially submitted to the FDA approximately one year ago. Since then, the Company has designed and filed a patent for a 3cc safety syringe that incorporates several changes and improvements, including a locking mechanism for the needle. The Company believes these improvements over the 12cc version will make the device easier to operate, easier to manufacture and safer to use. Because of the improvements, the Company believes that the 3cc safety syringe will meet the "substantial equivalence" requirements for a Class I device. The lack of a locking mechanism was one of the reasons the FDA reclassified the 12cc syringe to a Class III device. The Company does not plan to submit a PMA for the 12cc design. The Company is presently negotiating to license its 3cc safety syringe technology to a large plastics company. Maxxon is a development stage company committed to reducing the risk of accidental needlestick injuries and deaths to healthcare workers. Maxxon owns or is the licensee for safety needle technologies that retract the needle after use, thereby helping prevent a needlestick injury with a contaminated needle. The Company's products are in various stages of development and will require FDA approval before they can be sold in the United States. This press release contains some forward-looking statements. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-looking statements in this document should be evaluated together with the many uncertainties that affect our business. Those uncertainties are discussed in the Company's SEC filings. Maxxon, Inc. Investor Relations, 800/477-1805 www.maxxoninc.com businesswire.com Today's News On The Net - Business Wire's full file on the Internet with Hyperlinks to your home page. Copyright (C) 2002 Business Wire. All rights reserved.

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