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U.S. FDA Medical Device Oropharyngeal Airway Requirements


FDA Medical Device Definition: An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

Registrar Corp assists Oropharyngeal Airway companies with:

  • FDA Oropharyngeal Airway Establishment Registration
  • FDA Oropharyngeal Airway Listing
  • FDA Oropharyngeal Airway Label Requirements and Exceptions
  • FDA Oropharyngeal Airway Import Information
  • FDA Oropharyngeal Airway Detentions (Oropharyngeal Airway Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Oropharyngeal Airway Manufacturers (Oropharyngeal Airway Suppliers)
       - Oropharyngeal Airway Distributors
       - Oropharyngeal Airway Processors
       - Oropharyngeal Airway Repackers
       - Oropharyngeal Airway Relabelers
       - Oropharyngeal Airway Exporters
       - Oropharyngeal Airway Importers
For more information about Oropharyngeal Airway Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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