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FDA Product Code

FDA Product Code GCO — Clearance Directory

Device Class
Class II
21 CFR Citation
876.1500

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K862838 CYTOTECH HSV IGG ENZYME IMMUNOASSAY Cytotech, Inc. 1986-12-09 Traditional PDF ↗
K862717 HAND MIRROR (ENDOSCOPE) Simpson/Basye, Inc. 1986-07-30 Traditional PDF ↗
K790340 DELTA-ROL Johnson & Johnson Professionals, Inc. 1979-04-12 Traditional PDF ↗

Product code GCO · Class II · Gastroenterology, Urology. Data: openFDA.