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U.S. FDA Medical Device Specula Accessories 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 Specula Accessories companies with:

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