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U.S. FDA Medical Device Gingival Fluid Measurer Requirements


FDA Medical Device Definition: A gingival fluid measurer is a gauge device intended to measure the amount of fluid in the gingival sulcus (depression between the tooth and gums) to determine if there is a gingivitis condition.

Registrar Corp assists Gingival Fluid Measurer companies with:

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