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JAN 3 0 2013 510(k) SUMMARY A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 Submitter Information Name Address Phone number Fax number
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What is jan 3 0 510k?
The term 'jan 3 0 510k' refers to a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device.
Who is required to file jan 3 0 510k?
Manufacturers who intend to market a medical device in the United States are required to file a jan 3 0 510k submission with the FDA.
How to fill out jan 3 0 510k?
To fill out a jan 3 0 510k submission, manufacturers need to provide information on the device, its intended use, performance data, and comparisons to similar devices already on the market.
What is the purpose of jan 3 0 510k?
The purpose of a jan 3 0 510k submission is to demonstrate that a medical device is at least as safe and effective as a legally marketed device, thus allowing it to be marketed in the U.S.
What information must be reported on jan 3 0 510k?
Information on the device, its intended use, performance data, and comparisons to similar devices on the market must be reported in a jan 3 0 510k submission.
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