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510(k) K063694

AKREOS SINGLE USE INSERTION DEVICE, MODEL AI-28 by Bausch & Lomb, Inc. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2007
Date Received
December 13, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Guide, Intraocular
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

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