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.
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.
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