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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name camera, ophthalmic, ac-powered
510(k) Number K180306
Device Name Nexy
Applicant
Next Sight srl
Via IV Novembre 6/E
Limena,  IT 35010
Applicant Contact Arianna Dalla Ba
Correspondent
Next Sight srl
Via IV Novembre 6/E
Limena,  IT 35010
Correspondent Contact Arianna Dalla Ba
Regulation Number886.1120
Classification Product Code
HKI  
Date Received02/02/2018
Decision Date 06/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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