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510(k) K152602

Olea Sphere V3.0 by Olea Medical — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2016
Date Received
September 11, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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