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U.S. FDA Medical Device Jet Lavage Requirements

FDA Medical Device Definition: A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

Registrar Corp assists Jet Lavage companies with:

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