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510(k) K113785

ADHERENT VISUAL STIMULATOR GOGGLES by Anschel Technology, Inc. — Product Code GWE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2012
Date Received
December 23, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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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