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FDA Product Code

FDA Product Code QNS — Clearance Directory

Device Class
Class II
Assigned Panel
General Hospital
21 CFR Citation
880.5570

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K242956 LDS Needle; OcuSafe® LDS Needle; SteriCap® LDS Safety Needle; VitreJect® LDS Safety Needle Ocuject, LLC 2024-10-25 Special PDF ↗
K231734 STERiJECT Low Dead Space, STERiJECT The Invisible Needle Tsk Laboratory International Japan KK 2024-03-08 Traditional PDF ↗
K210444 EZ-Injec LDV Sterile Safety Needle Poonglim Pharmatech, Inc. 2021-02-16 Traditional PDF ↗

Product code QNS · Class II · General Hospital. Data: openFDA.