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MAR 1 2 2010
Exhibit #1510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in
accordance with the requirements of SM VDA 1990 and 21 CFR 807.92. The assigned
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01
To fill out the form assigned 510k number, follow these steps:
02
Start by entering the assigned 510k number in the designated field on the form.
03
Provide the necessary identification information, such as name, contact details, and address.
04
Fill out any required sections related to the product or device for which the 510k number is assigned.
05
Include any supporting documentation or additional information requested on the form.
06
Review the completed form for accuracy and completeness.
07
Sign and date the form as required.
08
Submit the filled-out form to the appropriate authority or regulatory body as instructed.
Who needs form assigned 510k number?
01
The form assigned 510k number is needed by medical device manufacturers and product distributors who wish to market a medical device in the United States.
02
It is a requirement by the U.S. Food and Drug Administration (FDA) for certain medical devices to undergo a premarket notification process, which involves obtaining a 510k number.
03
Therefore, companies or individuals involved in the manufacturing, importing, or distributing of medical devices that fall within the scope of FDA regulations need the form assigned 510k number.
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What is form assigned 510k number?
Form assigned 510k number is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a device that is already legally marketed.
Who is required to file form assigned 510k number?
Manufacturers of medical devices are required to file form assigned 510k number.
How to fill out form assigned 510k number?
Form assigned 510k number should be filled out by providing detailed information about the new medical device and its similarities to a legally marketed device.
What is the purpose of form assigned 510k number?
The purpose of form assigned 510k number is to demonstrate that a new medical device is as safe and effective as a device that is already on the market.
What information must be reported on form assigned 510k number?
Form assigned 510k number must include information about the new device, its indications for use, comparison to a legally marketed device, and any supporting data.
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