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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k150299 B. Purpose for Submission: Modification to the device to add compatibility
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Modification to form device is any changes or alterations made to a previously submitted form device.
Any individual or entity who has made changes to a form device is required to file a modification.
To fill out a modification to form device, the individual or entity must provide details of the changes made and any supporting documentation.
The purpose of modification to form device is to update any relevant information and ensure that the form device is accurate and up to date.
The information reported on a modification to form device should include details of the changes made, reasons for the changes, and any impact on the form device.
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