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U.S. FDA Medical Device Operating-Room Stool Requirements

FDA Medical Device Definition: A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

Registrar Corp assists Operating-Room Stool companies with:

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