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510(k) K112977

MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) by Alcon Research, Ltd. — Product Code MSS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2012
Date Received
October 6, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type

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