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FDA 510k Submission & Approval Timeline FDA 510k Submission & Documentation Fees (510K Consulting, Preparation, Pre-submission, Final Submission & US Agent) US FDA Medical Device Establishment Registration FY 2024 Fees: $7653 FDA 510k Review Fee FY-2024 (Standard): $21760 FDA 510k Review Fee FY-2024 (Small Business): $5440 Clients may make the above payments directly to the US FDA OPTION 1: FDA 510k Complete Package Fees Payable to MedDeviceCorp [Oct 2024 Sep 2025] OPTION 2: FDA 510k Partial Service Fees Payable to MedDeviceCorp [Oct 2024 Sep 2025] Important Information Country-specific Government taxes are additional

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