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U.S. FDA Medical Device Filiform & Filiform Follower Requirements


FDA Medical Device Definition: A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower.

Registrar Corp assists Filiform & Filiform Follower companies with:

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