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U.S. FDA Medical Device Paraffin Ovens 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 Paraffin Ovens companies with:

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