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

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