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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biomicroscope, Slit-Lamp, Ac-Powered
510(k) Number K160327
Device Name ALADDIN HW3.0
Applicant
VISIA IMAGING S.R.L
VIA MARTIRI DELLA LIBERTA 95/E
San Giovanni Valdarno,  IT 52027
Applicant Contact Silvia Fantechi
Correspondent
THEMA S.R.L
VIA SARAGAT 5
Imola,  IT 40026
Correspondent Contact Marisa Testa
Regulation Number886.1850
Classification Product Code
HJO  
Date Received02/05/2016
Decision Date 10/05/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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