FDA 510(k), K220540, ProGrip Self-Gripping Polypropylene Mesh

510(K) Number: K220540
Device Name: ProGrip Self-Gripping Polypropylene Mesh
Manufacturer: Jonas Gulmez
Device Classification Name: Mesh, Surgical, Polymeric
Regulation Number: FTL
Classification Product Code: KXA
Date Received: 02/25/2022
Decision Date: 09/22/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery

634 pages (335 of 969 original pages are fully redacted)