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Click ‘Get Form’ to open it in the editor.
Begin by filling out the 'Submitter' section. Enter the name, street address, ZIP/postal code, city, federal state, country, establishment registration number, contact name, phone number, fax number, and email.
In the 'Name of Device' section, provide the proprietary name, classification name, and common name of the device.
List all predicate devices in the designated area. Ensure accuracy as this information is crucial for regulatory compliance.
Complete the 'Description for the Premarket Notification' section by detailing intended use and technological characteristics of your device.
Review all entries for completeness and accuracy before submitting your form through our platform.
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A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act) that is not subject to premarket approval.
What is the difference between a 510k statement and a summary?
510(k) Summary or 510(k) Statement A 510(k) Summary is a condensed version of all the content of your 510(k). It will be made available to the public 30 days after your 510(k) is cleared, so be mindful of the details you include! The FDA website provides guidance on the content of your 510(k) summary.
How to search 510k?
Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.
How to search for FDA number?
Step by Step instruction to search Drug establishment registration number. Click on the below link. . Enter the company name in query box. After you perform search action , name of the establishment, address and validity of the registration will appear.
Is 510k the same as FDA approval?
The 510(k) clearance process doesnt require companies to provide safety or effectiveness data from clinical trials. But the FDA still evaluates the devices safety and effectiveness by comparing it to other devices. The FDA requires that companies submit a 510(k) at least 90 days before marketing the device.
Related Searches
K242987 fda 510kPending 510 kList of Class B medical devices FDAFDA Product Code gadDevices at FDADe Novo 510kFDA medFDA investigational device Exemption database
Go to the Devices@FDA Database. In the Enter a search term in the space below field, type the name of the device or the company name. You can type the exact name of a specific device or a generic name for a category of devices (such as pacemaker). Click Search.
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