Home / 510(k) Clearances / DEN200063

510(k) DEN200063

Kerasave by Al.Chi.Mi.A. S.R.L — Product Code QCW

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: May 2, 2022
Date Received: October 1, 2020
Clearance Type: Post-NSE
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Corneal Storage Media With Preservatives Including Anti-Fungal
Device Class: Class II
Regulation Number: 886.4320
Review Panel: OP
Submission Type

Media to preserve human corneas while in storage.