Food and Drug Administration (Department of Health and Human Services)

On November 5, 1999, the FDA issued to ProSolv a substantial equivalence determination based upon its 510(k) registration (Number K993750). On September 16, 2002, the FDA issued to ProSolv a 510(k) substantial equivalence determination based upon its second 510(k) registration for its expanded product line (Number K023112). ProSolv maintains a comprehensive quality system in accordance with the applicable regulatory requirements under the Code of Federal Regulations, Title 21, Parts 800 to 898. Under these regulations, the ProSolv product is defined as a Class 2 medical device.