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U.S. FDA Medical Device Suture Retention Device Requirements


FDA Medical Device Definition: A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.

Registrar Corp assists Suture Retention Device companies with:

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