The 3 Types of 510(k) Submissions

(3:53)

Mastering your 510(k) submission process

(1:6:28)

Basics of 510(k) Clearance Process

(2:17)

Understanding the FDA Medical Device 510k Process

(2:19)

Regulatory Compliance through 510(k) Application: Basic Guide for U.S. Medical Device Market Entry

(9:4)

How to Prepare a Medical Device 510k Submission for FDA

(11:6)

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

(1:16)

510(k) Tips and Tricks

(12:15)

Webinar for Special 510(k) Submissions

(52:43)

Genji Main Plays Overwatch After 2 Months (T.H.E F.A.S.T D.A.S.H.A) (Clip) PT.1

(27)

Using the new eSTAR templates for a 510(k) submission and the FDA eSTAR draft guidance

(37:47)

510k Myth - Not Required for Class 1 Medical Devices

(3:40)

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

(4:11)

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

(1:25:43)

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

(19:8)

How to Prepare a Medical Device 510k Submission for FDA | Rob Packard | Joe Hage

(1:34:30)

ApolloHipX™ FDA 510(k) clearance announcement

(1:31)

What Is The 510(k) Process? | Madris Tomes, CEO of Device Events

(1:45)

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

(1:18:15)

510(k) Submission Predicate Selection Webinar - Updated for 2022

(6:34)