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U.S. FDA Medical Device Surgical Skin Degreaser Requirements


FDA Medical Device Definition: A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape.

Registrar Corp assists Surgical Skin Degreaser companies with:

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