U.S. FDA Medical Device Eustachian Bougie Requirements
FDA Medical Device Definition: A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.
FDA Eustachian Bougie Label Requirements and Exceptions
FDA Eustachian Bougie Import Information
FDA Eustachian Bougie Detentions (Eustachian Bougie Entry Refusals)
General U.S. Food and Drug Administration Medical Device Guidelines for:
- Eustachian Bougie Manufacturers (Eustachian Bougie Suppliers)
- Eustachian Bougie Distributors
- Eustachian Bougie Processors
- Eustachian Bougie Repackers
- Eustachian Bougie Relabelers
- Eustachian Bougie Exporters
- Eustachian Bougie Importers
For more information about Eustachian Bougie Medical Devices, simply click below:
U.S. FDA Regulations:
U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.
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