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U.S. FDA Medical Device Powered Nasal Irrigator Requirements


FDA Medical Device Definition: A powered nasal irrigator is an AC-powered device intended to wash the nasal cavity by means of a pressure-controlled pulsating stream of water. The device consists of a control unit and pump connected to a spray tube and nozzle.

Registrar Corp assists Powered Nasal Irrigator companies with:

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