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U.S. FDA Medical Device Vaginal Insufflator Requirements

FDA Medical Device Definition: A vaginal insufflator is a device used to treat vaginitis by introducing medicated powder from a hand-held bulb into the vagina through an open speculum

Registrar Corp assists Vaginal Insufflator companies with:

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