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Introduction 0 hr 2 min
- What is 510(k)?
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Why 510(k)? 0 hr 1 min
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510(k) and the other FDA Pathways 0 hr 3 min
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Classification and Substantial Equivalence 0 hr 2 min
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Determining Equivalence 0 hr 2 min
- What has to be included?
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Required Sections for a 510(k) submission 0 hr 3 min
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A Few Pointers 0 hr 6 min
- Other Tips and Tricks
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510(k) Types 0 hr 4 min
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Most Common Rejection Reasons 0 hr 3 min
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Understanding the FDA Review Process 0 hr 5 min
- Summary
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Wrapping things up... 0 hr 2 min
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Conclusion 0 hr 1 min
FDA 510(k) Overview
Get to know this common FDA clearance path and understand when you'll need to use it.
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