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HENDERSON, Nev., Oct. 04, 2019 (GLOBE NEWSWIRE) -- United Health Products, Inc. (UHP) (OTC: UEEC) today announced that it has submitted a Premarket Approval (PMA) application for Class III approval to the FDA for HemoStyp.
The PMA program confirms the safety and efficacy of a product. If approved, UHP expects that HemoStyp will be authorized for use in surgical procedures in abdominal, cardiovascular, thoracic and vascular surgeries per UHP’s PMA filed Instructions For Use. HemoStyp’s PMA application falls under SUBCHAPTER H--MEDICAL DEVICES PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES. Subpart E--Surgical Devices Sec. 878.4490 Absorbable hemostatic agent and dressing. An absorbable hemostatic agent or dressing is a device intended to produce hemostasis by accelerating the clotting process of blood. It is absorbable; is intended for internal surgical use; and, is classified as a Class III device.
About United Health Products
UHP develops, manufactures, and markets patented hemostatic gauze for the healthcare and wound care sectors. Its proprietary product, HemoStyp®, is derived from regenerated oxidized cellulose, which is all natural, is designed to absorb exudate/drainage from superficial wounds, and helps control bleeding. UHP is focused on identifying new markets and applications for its products, and expanding its current markets. For more on UHP visit: www.unitedhealthproductsinc.com
Safe Harbor Statement
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This news release may contain forward-looking information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements that include the words "believes," "expects," "anticipates" or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to differ materially from those expressed or implied by such forward-looking statements.
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