FDAnews
www.fdanews.com/articles/69830-nephros-announces-510-k-filing-for-olpur-hd190-high-flux-filter

Nephros Announces 510(k) Filing for OLpur HD190 High Flux Filter

March 14, 2005

Nephros announced that it has provided a 510(k) submission for its OLpur HD190 to the FDA. The company's OLpur HD190 is a high flux filter designed for use in a variety of End Stage Renal Disease (ESRD) therapies, including dialysis and hemodiafiltration. Submission of form 510(k) is the first step for Nephros in the regulatory process to gain approval for its ESRD therapies in the U.S.

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