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510(k) K945270

CUSTOM ARTIFICIAL HUMAN EYES by Daniel T Acosta — Product Code HQH

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 30, 1995
Date Received: October 28, 1994
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Eye, Artificial, Non-Custom
Device Class: Class I
Regulation Number: 886.3200
Review Panel: OP
Submission Type