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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 K190875
Device Name EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)
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
HQE   HQF  
Date Received04/04/2019
Decision Date 09/25/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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