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U.S. FDA Medical Device Biopsy Forceps Cover Requirements

FDA Medical Device Definition: A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Registrar Corp assists Biopsy Forceps Cover companies with:

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