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510(k) K063155

MONARCH III IOL DELIVERY SYSTEM by Alcon Manufacturing, Ltd. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2007
Date Received
October 17, 2006
Clearance Type
Traditional
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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  • K093210 — AQUALASE CAPSULE WASH TIP (March 4, 2010)

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