shanemason687
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| 510K SUBMISSION (16th May 25 at 5:04am UTC)
510K SUBMISSION | | Medical device makers use the 510k premarket notification to legally market a new medical device. This procedure necessitates the submission of technical data to the Food and Drug Administration (FDA) on a prescribed form known as a Premarket Notification (510k) Application, which is then examined by FDA scientists for safety, effectiveness, and labelling. A company’s 510k submission is a crucial document. It certifies to the agency that your product complies with public health and safety regulations, allowing you to list it as an FDA-approved device on your marketing labels.
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Hello bloggers! I am a business executive with over 10 years of experience in iso 9001 certification. I created this profile to share my knowledge on this topic and to learn from others. I look forward to seeing your comments! |
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