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SUMMARY AND CERTIFICATION 510(k) SUMMARY Submitted by: Scott Makovich Quantum Medical Imaging, LLC. 2905 Veterans Memorial Highway Ronkonkoma, NY 11779 USA September 3, 2002, This 510(k) summary of
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How to fill out summary and certification 510k
How to fill out summary and certification 510k
01
Gather all relevant information about the medical device being submitted for 510k approval.
02
Complete the required sections of the summary document including device description, intended use, and technological characteristics.
03
Provide detailed information on the safety and effectiveness of the device, including any clinical data or testing results.
04
Fill out the certification section accurately, verifying that all information provided is true and complete.
05
Review and double-check the summary and certification documents for accuracy and completeness before submitting them for approval.
Who needs summary and certification 510k?
01
Companies and individuals who are seeking approval from the Food and Drug Administration (FDA) to market a new medical device in the United States.
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What is summary and certification 510k?
Summary and Certification 510k is a document required by the FDA for medical device manufacturers to demonstrate that their product is substantially equivalent to a legally marketed device. It includes a summary of the device, its intended use, and supporting data.
Who is required to file summary and certification 510k?
Medical device manufacturers who are seeking marketing approval for their device in the United States are required to file summary and certification 510k.
How to fill out summary and certification 510k?
To fill out summary and certification 510k, manufacturers must provide detailed information about their device, its intended use, and any existing similar devices on the market. They must also include supporting data and evidence of the device's safety and effectiveness.
What is the purpose of summary and certification 510k?
The purpose of summary and certification 510k is to demonstrate that a medical device is substantially equivalent to a legally marketed device in order to receive marketing approval from the FDA.
What information must be reported on summary and certification 510k?
Information that must be reported on summary and certification 510k includes device description, intended use, indications for use, and a comparison to a legally marketed device.
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