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510(k) K191051

ARGOS by Santec Corporation — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2019
Date Received
April 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

Other clearances by Santec Corporation

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