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U.S. FDA Medical Device Tissue Cassettes Requirements

FDA Medical Device Definition: A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.

Registrar Corp assists Tissue Cassettes companies with:

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