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Posted: Saturday, 5 November 2016, 23:57

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PREMARKET NOTIFICATION 510(k)


FDA REGISTRATION of your Dutch Medical Device Company


Premarket Notification, also known as FDA 510(k), is one of the first steps for medical device companies that manufacture Class II medical devices (and a small number of Class I devices).


WHAT'S INCLUDED?

U. S. Agent service.
Medical Device Establishment registration.
Medical Device listing.
We evaluate the classification of your medical device and determine the proper FDA product code and regulation number.
We determine which similar (predicate) devices already have FDA 510(k) clearance and whether they are suitable for use in your 510(k) submission.
Prepare all 21 sections of the FDA 510(k) application.
Coordinate your payment of FDA 510(k) submission fees on your behalf.
Submit the 510(k) to the FDA and answer follow-up questions from the FDA  reviewer.
Upon clearance of your device, we register your establishment with the FDA.


CONTACT US | Monday - Saturday | 3:00 AM - 6:00 PM EST

ITB HOLDINGS LLC | www.m.itbhdg.com | www.itbhdg.com | T : +1 855 510 2240 | T : +1 855 389 7344 | T : +44 800 610 1577

SAVE TIME and MONEY

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PREMARKET NOTIFICATION 510(k) | FDA REGISTRATION of your Dutch Medical Device Company | Save time and money Now @ ITB HOLDINGS LLC | www.m.itbhdg.com | www.itbhdg.com | http://www.itbhdg.com/english/medical-devices.php

• Location: Amsterdam

• Post ID: 3748712 nederland
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