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U.S. FDA Medical Device Hernia Support Requirements

FDA Medical Device Definition: A hernia support is a device, usually made of elastic, canvas, leather, or metal, that is intended to be placed over a hernial opening (a weakness in the abdominal wall) to prevent protrusion of the abdominal contents. This generic type of device includes the umbilical truss.

Registrar Corp assists Hernia Support companies with:

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