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PARAvnC4U 510(K) Summary Date 0 i14/. It is The following Special 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92(c). Manufacturer InformxationDEC 0 62012Manufacturer:Paraded.

How to fill out form special 510k program

How to fill out form special 510k program

1. Step 1: Obtain the appropriate form special 510k program from the regulatory authority.
2. Step 2: Familiarize yourself with the specific requirements and guidelines outlined in the form.
3. Step 3: Provide detailed information about the medical device for which you are seeking clearance.
4. Step 4: Clearly state the modifications or changes made to the device compared to its predicate device.
5. Step 5: Include any relevant supporting documentation, such as test reports, clinical data, and risk assessments.
6. Step 6: Submit the completed form and all necessary supporting documents to the regulatory authority.
7. Step 7: Pay any applicable fees and await feedback from the regulatory authority.
8. Step 8: Address any requests for additional information or clarification promptly.
9. Step 9: Receive the final decision from the regulatory authority regarding the special 510k program.

Who needs form special 510k program?

1. Medical device manufacturers who have made modifications to their devices that do not significantly affect their safety or effectiveness, but still require clearance from the regulatory authority.

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What is form special 510k program?

Form Special 510(k) program is a regulatory pathway for medical devices that are considered to be a moderate risk and modifications to an existing device that has already received 510(k) clearance.

Who is required to file form special 510k program?

Manufacturers or distributors who are seeking clearance for modifications to an existing device that has already received 510(k) clearance.

How to fill out form special 510k program?

Form Special 510(k) must be completed with all necessary technical and clinical information related to the modifications made to the existing device.

What is the purpose of form special 510k program?

The purpose of form special 510(k) program is to ensure that modifications made to existing medical devices do not compromise safety and effectiveness.

What information must be reported on form special 510k program?

The form must include detailed information about the modifications made to the existing device, as well as any new risks or hazards that may have been introduced.