FDA 510(k) Applications Submitted by Stephanie Saati

FDA 510(k) Number Submission Date Device Name Applicant
K180829 03/30/2018 PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh Ethicon, Inc
K172089 07/11/2017 PROLENE Soft Polypropylene Mesh Ethicon, Inc.
K183183 11/19/2018 VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture Ethicon, Inc.


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