Get the free 510(k) Summary Pursuant to 21 CFR 807.92 - FDA
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T 'I 'Aerodynamics, Inc. Duramax Chronic Hemodialysis Catheter and Procedure Kit 5 10(k) Pre-market Notification 5. 510(K) SUMMARY AS REQUIRED BY 21 CFR 807.92OCT 2 02010Submitter: Aerodynamics Inc.
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How to fill out 510k summary pursuant to
How to fill out 510k summary pursuant to
01
To fill out the 510k summary pursuant to, follow these steps:
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- Step 1: Begin by providing general information about the medical device, such as its name, manufacturer, and intended use.
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- Step 2: Include a detailed description of the device, its components, and how it functions.
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- Step 3: Provide information about any performance testing or clinical studies conducted on the device.
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- Step 4: Include any relevant labeling, instructions for use, or patient information that accompanies the device.
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- Step 5: Summarize the device's safety and effectiveness, highlighting any specific risks or benefits.
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- Step 6: Include a comparison to similar devices already on the market, demonstrating the device's similarities and differences.
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- Step 7: Complete the summary by providing any additional information that may be relevant for the review process.
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By following these steps, you can effectively fill out the 510k summary pursuant to.
Who needs 510k summary pursuant to?
01
The 510k summary pursuant to is needed by medical device manufacturers who are seeking clearance from the U.S. Food and Drug Administration (FDA) to market their device.
02
It is required for medical devices that are considered moderate to high risk and do not meet the criteria for a substantial equivalence to a legally marketed device.
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Thus, manufacturers who need to demonstrate the safety and effectiveness of their device to the FDA will require a 510k summary pursuant to.
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What is 510k summary pursuant to?
The 510(k) summary is a document submitted to the FDA as part of the premarket notification process detailing information about a medical device that demonstrates it is safe and effective compared to an already legally marketed device.
Who is required to file 510k summary pursuant to?
Manufacturers who wish to market a medical device that is substantially equivalent to a device already on the market must file a 510(k) summary with the FDA.
How to fill out 510k summary pursuant to?
Filling out a 510(k) summary involves providing specific information about the device, including its intended use, technological characteristics, and performance data. Detailed instructions can be found on the FDA's website.
What is the purpose of 510k summary pursuant to?
The purpose of the 510(k) summary is to provide the FDA with enough information to determine whether the new device is substantially equivalent to a previously cleared device, thus allowing it to be marketed.
What information must be reported on 510k summary pursuant to?
The 510(k) summary must include information about the device's name, manufacturer, intended use, description, substantial equivalence, labeling, and any performance testing results.
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