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

FDA Medical Device Definition: An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percentl-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures;" it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached

Registrar Corp assists Absorbable Poly Surgical Suture companies with:

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