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U.S. FDA Medical Device Rotary Microtome 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 Rotary Microtome companies with:

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