Get the free 510 (k) Number K131917 - accessdata fda

An r SAP CHIVIED 510(k) Summary 510 (k) Number: K131917 Date of Submission: April 29, 2014, Submitter: BLAMED EQUIPMENTS MEDICOS Agenda Dr. Carlos Burgos 2800 Amparo São Paulo Brazil TEL FAX 551938179633

How to fill out 510 k number k131917

How to fill out 510 k number k131917:

1. Start by gathering all the necessary information and documents required for the 510 k submission.
2. Begin filling out the application form by providing accurate and detailed information about the medical device being submitted for clearance.
3. Include all relevant product details such as the device's intended use, design specifications, components, materials, and any previous modifications made.
4. Clearly outline the safety and effectiveness of the device, providing supporting data and test results obtained during the device's development and evaluation.
5. If applicable, include any clinical data or studies conducted to demonstrate the device's safety and performance.
6. Ensure that all sections of the application form, including administrative, labeling, and manufacturing information, are accurately completed.
7. Double-check the application for any errors or missing information before submission.
8. Submit the completed 510 k application, along with any supporting documents, to the appropriate regulatory authority.

Who needs 510 k number k131917:

1. Manufacturers or developers of medical devices that fall under the scope of the United States Food and Drug Administration (FDA) regulations.
2. Companies seeking to market their medical devices within the United States.
3. Any organization or individual required to obtain FDA clearance for their medical device before it can be legally sold or distributed in the US market.

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