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510(k) K182659

Galilei G6 Lens Professional by Sis Ag, Surgical Instrument Systems — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2019
Date Received
September 25, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Analysis, Anterior Segment
Device Class
Class II
Regulation Number
886.1850
Review Panel
OP
Submission Type

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