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U.S. FDA Medical Device Gynecological Biopsy Forceps 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. This type of device consists of the following:

Registrar Corp assists Gynecological Biopsy Forceps companies with:

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