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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
Predetermined Change
Control Plan Authorized		 No
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