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510(k) Premarket Notification GE Venue 40 Compact Ultrasound March 20, 2009 #OF Attachment B Summary of Safety and Effectiveness Prepare din accordance with 21 CFR Part 807.92(c). GE Healthcare GE
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How to fill out 510k premarket notification ge
How to fill out 510k premarket notification ge:
01
Gather all necessary information and documents such as device labeling, instructions for use, and technical specifications.
02
Determine the appropriate product code for your device using the FDA's Product Code Builder tool.
03
Prepare a cover letter that includes your contact information, a brief description of the device, and a statement of the intended use.
04
Complete the required sections of Form FDA 3514, which includes information about the device manufacturer, device description, and device classification.
05
Include any applicable clinical data, performance testing results, and risk assessment documentation.
06
Submit the completed 510k premarket notification, along with all supporting documents, to the FDA either through the online eSubmitter system or by mailing a physical copy.
07
Monitor the status of your submission through the FDA's online tracking system and respond promptly to any requests for additional information or clarification from the FDA.
Who needs 510k premarket notification ge:
01
Manufacturers of medical devices that are new to the market or have undergone significant changes that could affect their safety or effectiveness.
02
Companies seeking FDA clearance to market their medical devices in the United States.
03
Any manufacturer planning to introduce a new medical device that is not exempt from the 510k requirements specified by the FDA.
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