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K140715 Page 1 of 2 510(k) Summary Art Contact: Justin Angleton Musculoskeletal Clinical & Regulatory Advisers, LLC 1331 H Street NW, 12 floor Washington, DC 20005 202.552.5800 Date Prepared: March

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What is k140715 - fda home?

K140715 - FDA Home is a form that must be filed with the Food and Drug Administration (FDA) by certain medical device establishments.

Who is required to file k140715 - fda home?

Medical device establishments that are registered with the FDA are required to file k140715 - fda home.

How to fill out k140715 - fda home?

K140715 - FDA Home can be filled out electronically through the FDA's Electronic Submissions Gateway.

What is the purpose of k140715 - fda home?

The purpose of k140715 - fda home is to provide the FDA with updated information about medical device establishments.

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Information such as the establishment's address, contact information, and types of devices manufactured must be reported on k140715 - fda home.

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