Question: medical patch designed was somewhat flawed. The adhesive used to keep the patch in place is not as strong as previously thought. Since the patch

medical patch designed was somewhat flawed. The adhesive used to keep the patch in place is not as strong as previously thought. Since the patch must remain in place for 24 hours, it is imperative that this adhesive work well. So, your company decides to investigate alternative adhesives to use in the next design phase. Ultimately, a new adhesive is discovered and it shows a greater level of efficacy for the vaccine patch since the patch is staying in place for the required 24 hours. Why or why should a 510 (k) be filed if it's just adjustment to the same product

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