FDA Registration Medical Devices

Offering an article that is a drug or medical device for import without establishment registration, is illegal. Even when a Premarket Notification 510(k) is not required, it is necessary to meet other requirements.
ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States
T: +1 855-389-7344
T: +1 855-510-2240
T: +44 800-610-1577
www.usfda.info
www.usfda.info/fda-registration-services/