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2 510k Submission for the Pan Probe Biotech, Inc. Livestream human Chorionic Gonadotropin (Lives dream CG) h Rapid Urinary Pregnancy Test Immunoassay Devices Revised July 11, 2002, Pan Probe Biotech,
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What is 510k submission for form?
510k submission is a premarket notification submitted to the FDA for certain medical devices.
Who is required to file 510k submission for form?
Any person who intends to market a medical device in the United States is required to file a 510k submission.
How to fill out 510k submission for form?
To fill out a 510k submission, the person files a detailed report with information about the device, its intended use, and any scientific evidence of its safety and effectiveness.
What is the purpose of 510k submission for form?
The purpose of a 510k submission is to demonstrate that the medical device is substantially equivalent to a device that is already legally marketed.
What information must be reported on 510k submission for form?
The 510k submission must include information such as the device description, intended use, scientific justifications, sterilization methods, and labeling.
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