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510(k) K001157

MONARCH II IOL DELIVERY SYSTEM by Alcon Research, Ltd. — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 27, 2000
Date Received
April 10, 2000
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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