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510(k) K120104

VISIONSEARCH 1 by Visionsearch Pty, Ltd. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2012
Date Received
January 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stimulator, Photic, Evoked Response
Device Class
Class II
Regulation Number
882.1890
Review Panel
NE
Submission Type

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