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U.S. FDA Medical Device Rectal Dilator Requirements

FDA Medical Device Definition: A rectal dilator is a device designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument.

Registrar Corp assists Rectal Dilator companies with:

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