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Nephros Receives Formal Response from FDA for 510(k) Application for Hemodiafiltration System
Date:7/7/2010

s the issues raised in the current FDA letter as well as the process for moving forward.

Based upon the in-person meeting with the FDA reviewers, the company will determine the appropriate course of action, which could include filing a new 510(k) application or filing an appeal related to the current application.

Nephros has engaged King & Spalding LLP as regulatory counsel to advise the company in its next interactions with the FDA.  The company also intends to utilize the FDA's Ombudsman process.

Impact on Operations

The current decision by the U.S. FDA with regard to Nephros's HDF system does not impact the ability of the company to market and sell its mid-dilution (MD) filters for hemodiafiltration procedures outside of the U.S.

The Nephros dual stage ultrafilter (DSU) received 510(k) marketing clearance from the FDA in 2009 to be used to filter biological contaminants from water and bicarbonate concentrate used in hemodialysis procedures.  The 510(k) approval for the DSU filters is unrelated to the 510(k) application for the company's HDF system.

Nephros continues to work with STERIS Corporation under the development agreement executed in March 2010.

Nephros is continuing the development of its dual stage ultra reliable personal water filtration system under support from its U.S. Department of Defense appropriation.

About Nephros, Inc.

Nephros, Inc., headquartered in River Edge, New Jersey, is a medical device company developing and marketing filtration products for therapeutic applications, infection control, and water purification.

The Nephros hemodiafiltr
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SOURCE Nephros, Inc.
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6. Nephros Completes Pivotal U.S. Clinical Trial for its Hemodiafiltration Products
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