11/01/2022 Other Services
Most Class II (moderate risk) devices require a Premarket Notification 510(k) clearance from the FDA before they may be legally marketed.
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.itbhdg.com
https://www.itbholdingsllc.com/services/medical-devices-ppe/
Menstrual products (tampons, pads, menstrual cups) are regulated by the FDA as medical devices while intimate care products (douches, wipes, washes, s...
Menstrual products (tampons, pads, menstrual cups) are regulated by the FDA as medical devices while intimate care products (douches, wipes, washes, s...
ITB HOLDINGS LLC as your company’s FDA U.S. Agent for: Cosmetic Establishment Registration Drug Establishment Registration Medical Device Establishmen...
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the...
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