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510(k) K223074

CorNeat EverPatch by Corneat Vision , Ltd. — Product Code QWU

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 2, 2023
Date Received: September 30, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Prosthesis, Eyelid Spacer/Graft, Polymer
Device Class: Class II
Regulation Number: 886.3130
Review Panel: OP
Submission Type

For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid and eyelid area.