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510(k) K081877

ASSOCIATE 2500 DUAL AND COMPACT SYSTEMS by Dutch Ophthalmic Research Center International BV — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2009
Date Received
July 2, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Phacofragmentation
Device Class
Class II
Regulation Number
886.4670
Review Panel
OP
Submission Type

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