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U.S. FDA Medical Device Suction Operatory Unit Requirements


FDA Medical Device Definition: A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.

Registrar Corp assists Suction Operatory Unit companies with:

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