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FEB 182014 Section C 510(k) Summary 'This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SODA 1990 and 21 CPR 807.92. “The assigned

How to fill out section c 510k

How to fill out section c 510k:

1. Start by reviewing the instructions and guidelines provided for section c 510k. Familiarize yourself with the specific requirements and information that need to be included in this section.
2. Begin by entering the necessary identification details such as the product name, manufacturer, and any relevant identification numbers or codes.
3. Next, provide a concise and accurate description of the device being submitted for review. Include information about its intended use, design features, and any unique characteristics that set it apart from similar devices in the market.
4. Provide a summary of the technological characteristics of the device, highlighting any aspects that may impact its safety, effectiveness, or compatibility with other medical devices.
5. Include a brief overview of the device's performance specifications, such as its dimensions, weight, power requirements, and operational parameters.
6. If applicable, document any previous versions or iterations of the device that were submitted for FDA review. Specify any modifications or improvements made to the current version compared to the previous ones.
7. Describe any accessories or components that are intended to be used together with the device. Provide information on their design, purpose, and any potential influences on the device's performance or safety.
8. Discuss any available performance data or testing results that support the safety and effectiveness of the device. Include details on any standards or regulations that the device complies with.
9. Address any known risks or hazards associated with the device's use and outline the steps taken to mitigate these risks. This may include information on labeling, instructions for use, or additional safeguards implemented.
10. Finally, make sure to sign and date the section c 510k form to verify the accuracy and completeness of the information provided.

Who needs section c 510k:

1. Manufacturers or distributors of medical devices seeking clearance or approval from the Food and Drug Administration (FDA) typically need to fill out section c 510k.
2. Any company or individual introducing a new medical device to the U.S. market or making significant modifications to an existing device may be required to submit a section c 510k form.
3. Section c 510k is necessary for those seeking to demonstrate that their device is substantially equivalent to a legally marketed device, ensuring that it meets the necessary safety and effectiveness standards set by the FDA.

For pdfFiller’s FAQs

What is section c 510k?

Section C 510(k) is a premarket submission made to FDA to demonstrate that a medical device is substantially equivalent to a device that is already legally marketed.

Who is required to file section c 510k?

Manufacturers of medical devices are required to file section C 510(k) with the FDA.

How to fill out section c 510k?

Section C 510(k) should be filled out by providing detailed information about the medical device, its intended use, and comparing it to a legally marketed device.

What is the purpose of section c 510k?

The purpose of section C 510(k) is to demonstrate the safety and effectiveness of a medical device and show that it is substantially equivalent to a device already on the market.

What information must be reported on section c 510k?

Section C 510(k) must include information about the device description, intended use, materials, design, performance data, and labeling.

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