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Requirements for 510k Submission
Description: Submitting a 510(k) doesn’t mean you’re asking the FDA to approve your device as a brand-new innovation. Instead, it signals that your product is safe, effective, and comparable to what’s already available on the market. The Requirements for 510(k) Submission process is a regulatory pathway that medical device manufacturers must follow if they want to market their device in the U.S. A 510(k) submission demonstrates that your device.
https://tuffclassified.com/requirements-for-510k-submission_2575177
