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510(k) K111446

SOVEREIGN COMPACT PHACOEMULSIFICATION SYSTEM by Abbott Medical Optics, Inc. — Product Code HQC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2011
Date Received
May 24, 2011
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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