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FDA 510(k), K212797, iPrime Viscodelivery System
FDA 510(k), K212797, iPrime Viscodelivery System
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$149.00 USD
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510(K) Number: K212797
Device Name: iPrime Viscodelivery System
Manufacturer: Glaukos
Device Classification Name: Pump, Infusion, Ophthalmic
Regulation Number: 880.5725
Classification Product Code: MRH
Date Received: 09/02/2021
Decision Date: 01/06/2022
Regulation Medical Specialty: General Hospital
Device Name: iPrime Viscodelivery System
Manufacturer: Glaukos
Device Classification Name: Pump, Infusion, Ophthalmic
Regulation Number: 880.5725
Classification Product Code: MRH
Date Received: 09/02/2021
Decision Date: 01/06/2022
Regulation Medical Specialty: General Hospital
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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