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510(k) K123359

OVS1 VIDEO SYSTEM by Olive Medical Corp. — Product Code FCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2012
Date Received
October 31, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Source, Fiberoptic, Routine
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

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