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U.S. FDA Medical Device External Pelvimeter 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 External Pelvimeter companies with:

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