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510(k) K073508

PARKONE by Oculus Optikgerate GmbH — Product Code MXK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2008
Date Received
December 13, 2007
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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