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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 K142877
Device Name EVA,anterior machine, EVA, combined machine, EVA combined machine with laser(DORC connector), EVA combined machine with laser SMA connector)
Applicant
Dutch Ophthalmic Research Center International BV
Scheijdelveweg 2
Zuidland,  NL 3214 VN
Applicant Contact DANIELLE SLEEGERS
Correspondent
Dutch Ophthalmic Research Center International BV
Scheijdelveweg 2
Zuidland,  NL 3214 VN
Correspondent Contact DANIELLE SLEEGERS
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQE   HQF  
Date Received10/01/2014
Decision Date 03/13/2015
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
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