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U.S. FDA Medical Device Drape Adhesive Requirements

FDA Medical Device Definition: A drape adhesive is a device intended to be placed on the skin to attach a surgical drape.

Registrar Corp assists Drape Adhesive companies with:

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