3654-2026

1. Click ‘Get Form’ to open the 3654 in the editor.
2. Begin by selecting the type of 510(k) submission: Traditional, Special, or Abbreviated. This is crucial as it determines the subsequent fields you will need to complete.
3. Fill in the 'Standard Title' section with the appropriate title of the standard referenced in your submission.
4. Answer the questions regarding FDA recognition and testing conformity. Ensure you provide accurate details for each question, including any necessary FDA recognition numbers.
5. If applicable, complete the summary report table by detailing conformance with standard sections. Indicate whether each section is met and provide justifications for any deviations or options selected.
6. Review all entries for accuracy and completeness before finalizing your form. Utilize our platform's features to save your progress and make edits as needed.

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