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U.S. FDA Medical Device Airway (Extension) Connector Requirements

FDA Medical Device Definition: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

Registrar Corp assists Airway (Extension) Connector companies with:

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