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U.S. FDA Medical Device Metal Vaginal Speculum Requirements


FDA Medical Device Definition: An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

Registrar Corp assists Metal Vaginal Speculum companies with:

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