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U.S. FDA Medical Device Circumcision Shield Requirements

FDA Medical Device Definition: An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance.

Registrar Corp assists Circumcision Shield companies with:

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