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)CI UO Submitter: Pastilles Healthcare Hibernate Rain out Control System Premarket Notification: Traditional 510(k) 51 0(k) Summary Submitter NamePastillesex Group NV Division: Pastilles Healthcare
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What is fda k100104 form?
The FDA K100104 form is a specific form used by medical device manufacturers to report adverse events or malfunctions associated with their products to the U.S. Food and Drug Administration (FDA).
Who is required to file fda k100104 form?
Medical device manufacturers are required to file the FDA K100104 form whenever they become aware of any adverse events or malfunctions associated with their products.
How to fill out fda k100104 form?
To fill out the FDA K100104 form, medical device manufacturers need to provide details about the product, the adverse event or malfunction, and any known patient harm. They must also include their contact information and submit any supporting documentation.
What is the purpose of fda k100104 form?
The purpose of the FDA K100104 form is to ensure that the FDA receives timely and accurate information about adverse events and malfunctions associated with medical devices. This helps the FDA identify potential safety issues and take appropriate actions.
What information must be reported on fda k100104 form?
The FDA K100104 form requires medical device manufacturers to report information such as the product name and model, the date of the event, a description of the adverse event or malfunction, any known patient harm, and the actions taken to address the issue.
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