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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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What is modification to form device?
Modification to form device is any changes or alterations made to a previously submitted form device.
Who is required to file modification to form device?
Any individual or entity who has made changes to a form device is required to file a modification.
How to fill out modification to form device?
To fill out a modification to form device, the individual or entity must provide details of the changes made and any supporting documentation.
What is the purpose of modification to form device?
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.
What information must be reported on modification to form device?
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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