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U.S. FDA Medical Device Nasal Splint Requirements

FDA Medical Device Definition: An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose.

Registrar Corp assists Nasal Splint companies with:

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