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U.S. FDA Medical Device Therapeutic Scrotal Support Requirements


FDA Medical Device Definition: A therapeutic scrotal support is a device intended for medical purposes that consist of a pouch attached to an elastic waistband and that is used to support the scrotum (the sac that contains the testicles).

Registrar Corp assists Therapeutic Scrotal Support companies with:

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