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510(k) K221872

ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System by Nova Eye Inc. (Business Name Nova Eye Medical) — Product Code MPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2023
Date Received
June 28, 2022
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoilluminator
Device Class
Class II
Regulation Number
876.1500
Review Panel
OP
Submission Type

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