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Home » FDA: Angiodynamics Needs New 510(k) to Market Device as ‘Treatment’
FDA: Angiodynamics Needs New 510(k) to Market Device as ‘Treatment’
February 11, 2011
Angiodynamics has received an FDA warning letter for marketing its NanoKnife ablation device as a “treatment” and a “therapy” after agreeing not to use these terms.