U.S. FDA [510(k)] Third Party Review

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   Overview

FDA 510(k) Review
Review of 510(k) submittal on behalf of FDA (Food and Drug Administration). UL performs the review of the 510(k) application and recommends a substantial equivalence decision to the FDA. The FDA makes the final market clearance decision. Huge time saving! Market clearance can be achieved in 45 days or less.
















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