Understanding the FDA Medical Device 510k Process

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510(k) Tips and Tricks

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Mastering your 510(k) submission process

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How to Prepare a Medical Device 510k Submission for FDA

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Basics of 510(k) Clearance Process

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The 3 Types of 510(k) Submissions

(3:53)

ApolloHipX™ FDA 510(k) clearance announcement

(1:31)

510k Myth - Not Required for Class 1 Medical Devices

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Free Time #37

(1:47:54)

How Long Does a 510(k) Actually Take?

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10 Steps to Preparing Your 510(k) Submission (and How to Avoid the Common Pitfalls)

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510(k) eSTAR Webinar - Indications for Use and Classification

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What is the difference between a 510k and De Novo?

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The “New” 510(k): How Do You Show Substantial Equivalence without Using a Predicate?

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What Is The Special 510(k)? | Proxima CRO

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Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance

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What is the status of the 510(k) course?

(16:57)

Common 510(k) Mistakes

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What is a 510k? When Do I Need One? / Medical Device Regulations

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