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U.S. FDA Medical Device Intranasal Septal Splint Requirements


FDA Medical Device Definition: An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.

Registrar Corp assists Intranasal Septal Splint companies with:

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