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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Corneal Storage
510(k) Number K162013
Device Name Eusol-C
Applicant
Al.Chi.Mi.A. S.R.L
Viale Austria 14
Ponte San Nicolo,  IT 35020
Applicant Contact Mauro Beccaro
Correspondent
Al.Chi.Mi.A. S.R.L
1416 Obispo Ave.
Coral Gables,  FL  33134
Correspondent Contact Elena Morozova
Classification Product Code
LYX  
Date Received07/21/2016
Decision Date 09/15/2016
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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