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U.S. FDA Medical Device X-Ray Film Holder Requirements

FDA Medical Device Definition: A dental x-ray film holder is a device intended to position and to hold x-ray film inside the mouth.

Registrar Corp assists X-Ray Film Holder companies with:

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