www.fdanews.com/articles/71013-alliance-medical-receives-two-additional-510-k-clearances
Alliance Medical Receives Two Additional 510(k) Clearances
April 12, 2005
Alliance Medical, a reprocessor of single-use medical devices (SUDs), announced the FDA has cleared the final two 510(k)s filed by the company in response to the agency's supplemental validation submission request. The two clearances cover reprocessed electrophysiology (EP) catheters by Daig and EP Technologies. The FDA's decision to grant Alliance the 510(k) clearance illustrates Alliance's full compliance with the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
Genetic Engineering News (http://www.genengnews.com/news/bnitem.aspx?name=499944XSL_NEWSML_TO_NEWSML_WEB.xml)