IPrime Viscodelivery System

Pump, Infusion, Ophthalmic

Glaukos

The following data is part of a premarket notification filed by Glaukos with the FDA for Iprime Viscodelivery System.

Pre-market Notification Details

Device IDK212797
510k NumberK212797
Device Name:IPrime Viscodelivery System
ClassificationPump, Infusion, Ophthalmic
Applicant Glaukos 229 Avenida Fabricante San Clemente,  CA  92672
ContactAlex Bhaskarla
CorrespondentAlex Bhaskarla
Glaukos 229 Avenida Fabricante San Clemente,  CA  92672
Product CodeMRH  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-02
Decision Date2022-01-06

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