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U.S. FDA Medical Device Esthesiometer Requirements

FDA Medical Device Definition: An esthesiometer is a mechanical device which usually consists of a single rod or fiber which is held in the fingers of the physician or other examiner and which is used to determine whether a patient has tactile sensitivity.

Registrar Corp assists Esthesiometer companies with:

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