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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
Recalls CDRH Recalls
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