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510(K) Summary. 510(k) K120 Submitter: THE YESHIVA DENTAL MFC. CO., LTD 7 2012 DEC 1-3-6 Kobayashi, Sumida-ku Tokyo, Japan ZIP 130-8516 TEL: +81-3-3631-2165 (International Business Div.) FAX: +81-3-3631-2685
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What is 510k k120 submitter form?
The 510(k) K120 Submitter Form is a document submitted to the U.S. Food and Drug Administration (FDA) as part of the 510(k) premarket notification process for medical devices. It provides information about the submitter and their role in the application process.
Who is required to file 510k k120 submitter form?
Any organization or individual who is submitting a 510(k) application for a medical device to the FDA is required to fill out the 510(k) K120 Submitter Form.
How to fill out 510k k120 submitter form?
To fill out the 510(k) K120 Submitter Form, you need to provide information such as your organization's name, address, contact details, and a description of your role in the application process. It is important to accurately fill out all the required fields.
What is the purpose of 510k k120 submitter form?
The purpose of the 510(k) K120 Submitter Form is to capture information about the submitter of a 510(k) application. It helps the FDA track and identify the organization or individual responsible for the application and facilitates communication regarding the application.
What information must be reported on 510k k120 submitter form?
The 510(k) K120 Submitter Form requires information such as the submitter's organization name, address, contact person, phone number, email address, and a description of their role in the application process. Additional information related to the submission may also be required.
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