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510(k) K113696

OPTOS ADVANCE by Optos Plc. — Product Code NFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2012
Date Received
December 16, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Management, Ophthalmic
Device Class
Class II
Regulation Number
892.2050
Review Panel
OP
Submission Type

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