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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k070054 B. Purpose for Submission: Modification to device to incorporate a digital read-out of test

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What is modification to device to?

Modification to device to refers to any changes or alterations made to a device.

Who is required to file modification to device to?

The manufacturer or distributor of the device is required to file modification to device to.

How to fill out modification to device to?

Modification to device to can be filled out by submitting a written report detailing the changes made to the device.

What is the purpose of modification to device to?

The purpose of modification to device to is to ensure that the device continues to meet safety and performance standards.

What information must be reported on modification to device to?

Information such as the nature of the modification, its impact on device performance, and any testing results must be reported on modification to device to.

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