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510(k) K013110

ANISEIKONIA INSPECTOR by Optical Diagnostics, Inc. — Product Code HJT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 19, 2001
Date Received: July 11, 2001
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Haploscope
Device Class: Class I
Regulation Number: 886.1340
Review Panel: OP
Submission Type