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U.S. FDA Medical Device Infiltrator 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 Infiltrator companies with:

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