Breaking Records – Traditional FDA 510(k) Cleared in 18 Days

On August 14, 2020, Arazy Group received its fastest Traditional 510(k) clearance via the FDA’s new expedited 30-day Triage Quick route. This is an option that the Triage Quick program is offering any Traditional 510(k) submission that meets its criteria. The Traditional 510(k) submission, K202068, which was sent for Triage Quick review on July 27, (Read more...)

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