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U.S. FDA Medical Device Topical Approximation System Requirements


FDA Medical Device Definition: A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

Registrar Corp assists Topical Approximation System companies with:

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