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U.S. FDA Medical Device Surgical Camera Film Requirements


FDA Medical Device Definition: A surgical camera and accessories is a device intended to be used to record operative procedures.

Registrar Corp assists Surgical Camera Film companies with:

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