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SNote: If a device requires premarket notification clearance or approval it can ONLY be listed AFTER the premarket submission [510(k), PMA, PDP, HDE] is cleared or approved. If this is your only device listing, please do not register your establishment until after your premarket submission is cleared or approved. If your premarket submission is cleared or approved, you will need to do the following to list your device: Enter the premarket submission number Enter the proprietary name(s) Identify the activities that you perform on or to the device If your device is exempt from premarket notification/approval, you will need to do the following: Obtain the product code. You may click here to find your product code. Leave the premarket submission number blank Enter the product code in the filter box and click on "Filter" Select the radio button next to the product code and click "Continue" Identify the activities that you perform on or to the device Enter the proprietary name(s) For Initial Importers (facilities that take first title to a device imported into the United States): On the "Identify Manufacturers" page, click on the "Search & Add Products" button. Identify the manufacturer by using either its device listing number, establishment registration number, or establishment name and address. On the next page, under the registration information that matches the manufacturer of your devices, select the devices that you are importing and click on the "Add Selected Products" button. Certify that all the information is correct and click on the submit button. When prompted, enter both the PIN and PCN numbers that you received from the Office of Financial Management for your payment of the establishment registration fee. This information must be entered in order for FDA to accept your registration. If you are not prompted for the PIN/PCN numbers, please send an email to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete.  E

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