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Device Classification Name
corneal storage media with preservatives including anti-fungal
De Novo Number
DEN200063
Device Name
Kerasave
Requester
al.chi.mi.a. s.r.l
viale austria, 14
ponte san nicolo, IT 35020
Contact
mauro beccaro
Regulation Number
886.4320
Classification Product Code
QCW
Date Received
10/01/2020
Decision Date
05/02/2022
Decision
granted (DENG)
Classification Advisory Committee
Ophthalmic
Review Advisory Committee
Ophthalmic
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Post-NSE
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