510(k) K150754

ARGOS by Santec Corporation — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 2015
Date Received
March 23, 2015
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