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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name pump, infusion, ophthalmic
510(k) Number K212797
Device Name iPrime Viscodelivery System
Applicant
Glaukos
229 Avenida Fabricante
San Clemente,  CA  92672
Applicant Contact Alex Bhaskarla
Correspondent
Glaukos
229 Avenida Fabricante
San Clemente,  CA  92672
Correspondent Contact Alex Bhaskarla
Regulation Number880.5725
Classification Product Code
MRH  
Date Received09/02/2021
Decision Date 01/06/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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