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FDA Product Code

FDA Product Code PAI — Clearance Directory

Device Class
Class III
21 CFR Citation
884.5980

510(k) Clearances — 2 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K130006 BIODESIGN SURGISIS ANTERIOR POSTERIOR PELVIC FLOOR GRAFTS Cook Biotech Incorporated 2013-04-05 Traditional PDF ↗
K050355 PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 Tissue Science Laboratories, Plc 2005-03-09 Special PDF ↗

Product code PAI · Class III · Obstetrics/Gynecology. Data: openFDA.