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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K213467
Device Name EVA NEXUS Ophthalmic Surgical System
Applicant
D.O.R.C. Dutch Ophthalmic Research Center (International)
B.V.
Scheijdelveweg 2
Zuidland,  NL 3214 VN
Applicant Contact Linda van Leeuwen
Correspondent
D.O.R.C. Dutch Ophthalmic Research Center (International)
B.V.
Scheijdelveweg 2
Zuidland,  NL 3214 VN
Correspondent Contact Linda van Leeuwen
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
FMF   HQE   HQF  
Date Received10/28/2021
Decision Date 06/14/2022
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
Recalls CDRH Recalls
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