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U.S. FDA Medical Device Removable (Skin) Staple Requirements

FDA Medical Device Definition: A removable skin staple is a staple-like device intended to connect external tissues temporarily to aid healing. It is not absorbable.

Registrar Corp assists Removable (Skin) Staple companies with:

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