Project details

What is FDA 510(k) Clearances?

Section 510(k) of the Food, Drug and Cosmetic Act
Requires device manufacturers who must register
Notify FDA of their intent to market a medical device at least 90 days in advance
his is known as Premarket Notification – also called PMN or 510(k)
US FDA needs all formatlities to be completed
Post detailed review 510(k) clearance is provided by FDA

Field of LawBusiness (Corporate)

Target CountryWorldwide

LanguageEnglish

Service TypeLegal AssistanceWhat’s includedThese options are included with the project scope.

$750

• Delivery Time7 days
• Number of Revisions2

Portfolio

510 k approval fda medical devices510(k) clearance vs approval fda 510k guidance510k fda databasefda 510(k) database searchfda 510(k) submission 510k vs pma 510k medical device

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