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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
Predetermined Change
Control Plan Authorized		 No
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