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DCI 2.510(k)Summary.OCT 2 22010for Girona Dental Systems Girona Dental CAD/CAM System1 Sponsor Girona Dental Systems GmbH Fabrikstrasse 31 D64625 Bentham Germany Contact Person: Fritz Killed 49 6251

How to fill out hdci 2-510k

How to fill out hdci 2-510k

1. To fill out hdci 2-510k form, follow these steps:
2. Start by entering the required information in the top section of the form, such as your company name, address, and contact details.
3. Provide the necessary details about the device for which you are seeking 510k clearance. This includes the product name, intended use, and a brief description of the device.
4. Fill in the information about the device classification, including the applicable regulation number and product code.
5. Next, provide any known similar devices already on the market and their respective 510k numbers.
6. Specify whether the device is a modification or a new submission.
7. Include any relevant information about the pre-market notification, such as a summary of safety and effectiveness data, proposed labeling, and any clinical studies conducted.
8. Attach any supporting documentation or additional information as required.
9. Review the form for accuracy and completeness before submitting it.
10. Submit the hdci 2-510k form along with any applicable fees to the appropriate regulatory authority.
11. Keep a copy of the completed form and any supporting documents for your records.

Who needs hdci 2-510k?

1. HDCI 2-510k is needed by medical device companies that are seeking to market a new medical device in the United States.
2. Specifically, manufacturers, importers, and device distributors require hdci 2-510k clearance to demonstrate that their device is substantially equivalent to a legally marketed device and meets all the necessary safety and effectiveness requirements.
3. Healthcare professionals, regulatory specialists, and other stakeholders involved in the medical device industry may also refer to hdci 2-510k to understand the regulatory process and requirements for new medical devices.

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What is hdci 2-510k?

hdci 2-510k is a form required by the FDA for premarket notification of medical devices.

Who is required to file hdci 2-510k?

Manufacturers of medical devices intending to market their products in the United States are required to file hdci 2-510k.

How to fill out hdci 2-510k?

hdci 2-510k can be filled out online through the FDA's Electronic Submission Gateway.

What is the purpose of hdci 2-510k?

The purpose of hdci 2-510k is to demonstrate that a medical device is substantially equivalent to a legally marketed device.

What information must be reported on hdci 2-510k?

Information such as device description, indications for use, proposed labeling, and performance data must be reported on hdci 2-510k.