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U.S. FDA Medical Device ENT Speculum Requirements


FDA Medical Device Definition: A speculum is a device intended to be inserted into a body cavity to aid observation. It is either nonilluminated or illuminated and may have various accessories.

Registrar Corp assists ENT Speculum companies with:

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