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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ophthalmoscope, laser, scanning
510(k) Number K192113
Device Name DRSplus
Applicant
CenterVue SpA
Via S. Marco 9H
Padova,  IT 35129
Applicant Contact Roberto Gabriotti
Correspondent
CenterVue SpA
Via S. Marco 9H
Padova,  IT 35129
Correspondent Contact Roberto Gabriotti
Regulation Number886.1570
Classification Product Code
MYC  
Date Received08/05/2019
Decision Date 11/15/2019
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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