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U.S. FDA Medical Device Surgical Microscope Requirements

FDA Medical Device Definition: A surgical microscope and accessories is an AC-powered device intended for use during surgery to provide a magnified view of the surgical field.

Registrar Corp assists Surgical Microscope companies with:

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