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Posted by Khalid Shaikh on September 20, 2024 at 5:52pm 0 Comments 0 Likes
Posted by Khalid Shaikh on September 20, 2024 at 5:34pm 0 Comments 0 Likes
FDA 510k is a premarket approval process made by FDA to signify that the device to be marketed is at least as safe and effective, substantially equivalent, to a lawfully marketed device (21 CFR 807.92) that is not subject to premarket approval.
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