ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS

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 Associate 2500 Dual And Compact Systems.

Pre-market Notification Details

Device IDK081877
510k NumberK081877
Device Name:ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
ClassificationUnit, Phacofragmentation
Applicant DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEG 2 Zuidland,  NL 3214 Vn
ContactGer Vijfvinkel
CorrespondentGer Vijfvinkel
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV SCHEIJDELVEG 2 Zuidland,  NL 3214 Vn
Product CodeHQC  
CFR Regulation Number886.4670 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-02
Decision Date2009-01-05
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08717872016818 K081877 000
08717872009896 K081877 000
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08717872009728 K081877 000
08717872009711 K081877 000
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08717872008929 K081877 000
08717872002415 K081877 000
08717872017594 K081877 000
08717872016627 K081877 000
08717872013428 K081877 000
08717872001418 K081877 000
08717872013404 K081877 000
08717872013411 K081877 000
08717872009155 K081877 000
08717872009124 K081877 000
08717872009087 K081877 000
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08717872008950 K081877 000
08717872017686 K081877 000
08717872017679 K081877 000
08717872017174 K081877 000
08717872015026 K081877 000
08717872013503 K081877 000
08717872013442 K081877 000
08717872001395 K081877 000

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