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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 K213705
Device Name DRSplus
Applicant
Centervue S.P.A.
Via S. Marco 9h
Padova,  IT 35129
Applicant Contact Luca Scienza
Correspondent
Centervue S.P.A.
Via S. Marco 9h
Padova,  IT 35129
Correspondent Contact Luca Scienza
Regulation Number886.1570
Classification Product Code
MYC  
Date Received11/24/2021
Decision Date 12/21/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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