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FDA Product Code

FDA Product Code HJN — Clearance Directory

Device Class
Class I
Assigned Panel
Ophthalmic
21 CFR Citation
886.1945

510(k) Clearances — 3 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K941035 VENOSCOPE Trinity Partners, LLC 1994-05-16 Traditional PDF ↗
K912747 LULMITEX NEONATAL TRANSILLUMINATOR Lumitex, Inc. 1991-12-24 Traditional PDF ↗
K901309 SYLVAN PEDIASCAN 200 TRANSILLUMINATOR Sylvan Corp. 1990-05-24 Traditional PDF ↗

Product code HJN · Class I · Ophthalmic. Data: openFDA.