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U.S. FDA Medical Device Skin Closure System Requirements

FDA Medical Device Definition: A removable skin clip is a clip-like device intended to connect skin tissues temporarily to aid healing. It is not absorbable Skin_Marker=A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement.

Registrar Corp assists Skin Closure System companies with:

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