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The FDA's decision to grant Ascent the 510(k) clearance illustrates the Company's full compliance with the Medical Device User Fee and Modernization Act of 2002. 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 ( The inspection was directed from the Office of Compliance relating to the FDA's review of all Supplemental Validation Submissions (SVSs) on cleared 510(k) (premarket notifications) from reprocessing companies as directed by the Medical Device User Fee and Modernization Act of 2002 ( |
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