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FDA 510(k) Consulting Service for Medical Devices » Contact

1368 North US 1 – Suite 402 Ormond Beach, FL 32174 – USA. Phone: 386-868-0618 Fax: 386-274-5733 e-mail: [email protected] Business hours: Monday …


510(k) Clearances | FDA

Overview. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance.


Contact Us — FDA 510k Consultants, LLC

You can reach us by phone or email at any time. Rest assured that we will respond to you as soon as possible. by phone +1 (386) 243-4332 Our normal business hours are 10:00 AM to 10:00 PM ET. by email A member of our staff will return your message within 24 hours.


Search the Releasable 510(k) Database | FDA

You can search the releasable 510(k) database by Panel, 510(k) number, Product code or Device name. A search query will produce information from the database in the following format:


FDA 510(K) Submission | 510K Clearance (Approval) | FDA

FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.


FDA 510k Consultants for Submission & Approval Process

FDA 510k Consultants. We are FDA 510k Consultants We provide FDA approval, process & guidance. Our experienced consulting team guides you in the right direction about cost, requirements and, clearances. When bringing a medical device to market in the United States, based on the risk class and intended use of the device to determine whether to (a) submit a premarket notification, also known as