United States Eleventh Circuit

In an action by the U.S. to enjoin Defendants' manufacture of allegedly adulterated medical devices, judgment for Defendants is reversed, where Defendants advertised their devices for commercial distribution in violation of the FDA's "custom device" regulations.

Appellate Information

• Decided 03/30/2009
• Published 03/30/2009

Judges

• WILSON, Circuit Judge:, Before HULL, WILSON and HILL, Circuit Judges.

Court

• United States Eleventh Circuit

Counsel

• For Appellant:
  
• Irene M. Solet, Michael S. Raab, U.S. Dept. of Justice, Civ. Div., App. Staff, Washington, DC, for U.S., Vello Veski, Palm City, FL, for Endotec, Inc.