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Click ‘Get Form’ to open the c cSr - FDA document in the editor.
Begin by filling out the 'Submitters Information' section. Enter the name, address, phone number, and contact person details as required.
Proceed to the 'Device Name' section. Clearly specify the trade name, common name, classification name, and product code for your device.
In the 'Device Description' field, provide a detailed description of the device's functionality and any modifications made. Ensure clarity on how these changes enhance user convenience.
Complete the 'Indications for Use' section by stating that the device is indicated for acute and chronic dialysis therapy.
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