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U.S. FDA Medical Device Absorbable Surgical Gut Suture Requirements: Absorbable Surgical Gut Suture

FDA Medical Device Definition: An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation

Registrar Corp assists Absorbable Surgical Gut Suture companies with:

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




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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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