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FDA Product Code

FDA Product Code HJB — Clearance Directory

Device Class
Class I
Assigned Panel
Ophthalmic
21 CFR Citation
886.1450

510(k) Clearances — 5 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K930444 MARCO STANDARD KERATOMETERS Marco Ophthalmic, Inc. 1993-08-09 Traditional PDF ↗
K924779 BURTON KERATOMETER - MODLE 2040 R.H. Burton Co. 1993-04-05 Traditional PDF ↗
K864369 LTS CORNEAL MICROSCOPE LASER TOMOGRAPHIC SCANNER Heidelberg Instruments 1986-12-15 Traditional PDF ↗
K864037 KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER Kera Corp. 1986-11-13 Traditional PDF ↗
K852424 ACUFEX COMPARATIVE SURGICAL KERATOMETER Acufex Microsurgical, Inc. 1985-09-11 Traditional PDF ↗

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