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510(k) K212797

iPrime Viscodelivery System by Glaukos — Product Code MRH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2022
Date Received
September 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Ophthalmic
Device Class
Class II
Regulation Number
880.5725
Review Panel
OP
Submission Type

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