EVA,anterior Machine, EVA, Combined Machine, EVA Combined Machine With Laser(DORC Connector), EVA Combined Machine With Laser SMA Connector)

Unit, Phacofragmentation

DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV

The following data is part of a premarket notification filed by Dutch Ophthalmic Research Center International Bv with the FDA for Eva,anterior Machine, Eva, Combined Machine, Eva Combined Machine With Laser(dorc Connector), Eva Combined Machine With Laser Sma Connector).

Pre-market Notification Details

Device IDK142877
510k NumberK142877
Device Name:EVA,anterior Machine, EVA, Combined Machine, EVA Combined Machine With Laser(DORC Connector), EVA Combined Machine With Laser SMA Connector)
ClassificationUnit, Phacofragmentation
Applicant DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 Zuidland,  NL 3214 Vn
ContactDanielle Sleegers
CorrespondentDanielle Sleegers
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEWEG 2 Zuidland,  NL 3214 Vn
Product CodeHQC  
Subsequent Product CodeHQE
Subsequent Product CodeHQF
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-10-01
Decision Date2015-03-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08717872025988 K142877 000
08717872019697 K142877 000
08717872019703 K142877 000
08717872019710 K142877 000
18717872031481 K142877 000
08717872021041 K142877 000
08717872021508 K142877 000
08717872008837 K142877 000
08717872018645 K142877 000
08717872018706 K142877 000
08717872030579 K142877 000
08717872002972 K142877 000
08717872007199 K142877 000
08717872019680 K142877 000

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