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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY ONLY TEMPLATE. 510(k) Number:
k103295
B. Purpose for Submission:
Device Modification: Change in the cocaine cutoff concentration
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How to fill out device modification change in:
01
Begin by gathering all the necessary information and documents related to the device modification. This may include the device's serial number, model number, and any supporting documentation or certification.
02
Fill out the necessary sections of the device modification change form. This may include providing details about the modifications that were made, the purpose of the modification, and any potential risks or safety concerns associated with the modification.
03
If required, attach any additional supporting documents or evidence related to the modification. This may include engineering drawings, test reports, or certifications from relevant regulatory bodies.
04
Review the completed form and make sure all information provided is accurate and complete. Inaccurate or incomplete information may lead to delays or rejection of the modification change request.
05
Submit the filled-out form along with any supporting documents to the appropriate authority or department responsible for handling device modification change requests.
Who needs device modification change in:
01
Manufacturers or companies that have made modifications to their devices and need to update the relevant authorities or regulatory bodies about these changes.
02
Users or owners of devices who have made modifications and need to notify the manufacturer or relevant authorities.
03
Regulatory bodies or agencies responsible for monitoring and ensuring compliance with safety and quality standards for devices. These bodies may require companies and individuals to report any modifications made to devices under their jurisdiction.
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What is device modification change in?
Device modification change in is the process of making changes to a device's design, materials, components, or manufacturing process.
Who is required to file device modification change in?
Manufacturers, importers, and distributors of medical devices are required to file device modification change in.
How to fill out device modification change in?
Device modification change in can be filled out by providing details of the modification, rationale for the change, impact on device functionality and performance, and any testing or validation conducted.
What is the purpose of device modification change in?
The purpose of device modification change in is to ensure the safety, effectiveness, and quality of medical devices by tracking and evaluating any modifications.
What information must be reported on device modification change in?
Information such as the nature of the modification, reason for the change, testing or validation results, and any impact on device performance must be reported on device modification change in.
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