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510(k) K133352

HYPERSOUND AUDIO SYSTEM (HSS) by Hypersound Health, Inc. — Product Code EPF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2014
Date Received
October 31, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hearing Aid, Group And Auditory Trainer
Device Class
Class II
Regulation Number
874.3320
Review Panel
EN
Submission Type

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