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U.S. FDA Medical Device Tissue Grinder 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 Tissue Grinder companies with:

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