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U.S. FDA Medical Device Hypodermic Single Lumen Needle Requirements: Hypodermic Single Lumen Needle

FDA Medical Device Definition: A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set

Registrar Corp assists Hypodermic Single Lumen Needle companies with:

  • FDA Hypodermic Single Lumen Needle Establishment Registration
  • FDA Hypodermic Single Lumen Needle Listing
  • FDA Hypodermic Single Lumen Needle Label Requirements and Exceptions
  • FDA Hypodermic Single Lumen Needle Import Information
  • FDA Hypodermic Single Lumen Needle Detentions (Hypodermic Single Lumen Needle Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Hypodermic Single Lumen Needle Manufacturers (Hypodermic Single Lumen Needle Suppliers)
       - Hypodermic Single Lumen Needle Distributors
       - Hypodermic Single Lumen Needle Processors
       - Hypodermic Single Lumen Needle Repackers
       - Hypodermic Single Lumen Needle Relabelers
       - Hypodermic Single Lumen Needle Exporters
       - Hypodermic Single Lumen Needle Importers
For more information about Hypodermic Single Lumen Needle Medical Devices, simply click below:




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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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