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U.S. FDA Medical Device Penile Clamp Requirements

FDA Medical Device Definition: A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.

Registrar Corp assists Penile Clamp companies with:

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