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U.S. FDA Medical Device Embedding Container Requirements

FDA Medical Device Definition: Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

Registrar Corp assists Embedding Container companies with:

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