iPrime Viscodelivery System— 510(k) K212797

Substantially Equivalent

Glaukos

FDA 510(k) clearance K212797 for iPrime Viscodelivery System, Substantially Equivalent on 2022-01-06. Applicant: Glaukos. Device class: 2.

Clearance details

Applicant
Glaukos
Product code
Code MRH
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Clemente, CA, US
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