Get the free APR 510(k) Summary - - 1 20) K100724 This summary of 510(k) safety and effectiveness...
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APR 510(k) Summary
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What is apr 510k summary?
The apr 510k summary is a document that provides a concise summary of the safety and effectiveness information for a medical device, submitted as part of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA).
Who is required to file apr 510k summary?
Any manufacturer or distributor who intends to market a medical device in the United States is required to file an apr 510k summary as part of the 510(k) premarket notification process.
How to fill out apr 510k summary?
The apr 510k summary can be filled out by following the instructions provided by the FDA. It typically requires information about the device, its intended use, safety and effectiveness data, and any applicable predicate devices.
What is the purpose of apr 510k summary?
The purpose of the apr 510k summary is to provide a concise summary of the safety and effectiveness information for a medical device, which helps the FDA determine whether the device is substantially equivalent to a legally marketed predicate device.
What information must be reported on apr 510k summary?
The apr 510k summary must include information about the device, its intended use, summaries of the safety and effectiveness data, comparisons to predicate devices, and any applicable labeling changes.
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