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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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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 Number886.4320
Classification Product Code
QCW  
Date Received10/01/2020
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
Predetermined Change
Control Plan Authorized		 No
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