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510(k) K003768

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2001
Date Received
December 6, 2000
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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  • K101006 — WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 (October 21, 2010)

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