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U.S. FDA Medical Device Denis Brown Splint Requirements

FDA Medical Device Definition: A Denis Brown splint is a device intended for medical purposes to immobilize the foot. It is used on young children with tibial torsion (excessive rotation of the lower leg) or club foot. Densitometer/Scanner=A densitometer is a device used to measure the transmission of light through an indicator in a sample of blood.

Registrar Corp assists Denis Brown Splint companies with:

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