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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Analysis, Anterior Segment
510(k) Number K211868
Device Name MYAH
Applicant
Visia Imaging S.R.L.
Via Martiri Della Libertà, 95/E
San Giovanni Valdarno,  IT 52027
Applicant Contact Alessia Magnanini
Correspondent
Thema S.R.L.
Via Saragat,5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number886.1850
Classification Product Code
MXK  
Date Received06/16/2021
Decision Date 03/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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