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510(k) K823222

INTRAOCULAR LENS GUIDE by American Medical Optics — Product Code KYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 28, 1982
Date Received
October 29, 1982
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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  • K842197 — AMERICAN MEDICAL OPTICS I/A KIT- IRRIG (October 1, 1984)
  • K842127 — AMERICAN MEDICAL OPTICS IMAGING SYS (September 7, 1984)

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