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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 K081877
Device Name ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS
Applicant
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
SCHEIJDELVEG 2
ZUIDLAND,  NL 3214 VN
Applicant Contact GER VIJFVINKEL
Correspondent
DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
SCHEIJDELVEG 2
ZUIDLAND,  NL 3214 VN
Correspondent Contact GER VIJFVINKEL
Regulation Number886.4670
Classification Product Code
HQC  
Date Received07/02/2008
Decision Date 01/05/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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